Qualia Clinical Services | Research With Results

(Omaha, Nebraska – December 03, 2008) – Qualia Clinical Services is very pleased to announce the addition of Dr. Choo Pin Por to lead their Data Management & Regulatory Affairs departments. Dr. Por is welcomed with 10 years of experience in the pharmaceutical industry, most recently having served several roles for Novapharm Limited including Director of Biophamaceutics, Medical Information, Pharmacovigilance,and Regulatory Affairs. “Dr. Por’s proven background in leading and mentoring departments, and developing strategy and compliance processes is exactly what we need to further enhance the scope and level of services that we provide our clients,” stated Dr. Sohail Khattak, CEO. “Data Management and Regulatory Affairs are a very integral part of what we do at Qualia, and we are very confident that Dr. Por’s background and expertise can take us to the
next level.”

Qualia Clinical Services Business Development Team Expands to Cover all US Territories

(Omaha, Nebraska – October 21, 2008) – Qualia Clinical Services further expands its BD presence to best serve our clients nationally. Craig Miller will cover the North East region and Andrew Nehls will focus on the South East region.

Craig is an accomplished sales professional who has had a successful career in selling cardiac safety studies and all phases of clinical development. He has worked closely with small to mid size biotech and pharmaceutical companies and held a variety of BD sales management positions in the CRO industry.

Andrew has been Qualia from inception, therefore is very knowledgeable of Qualia’s capabilities. He is in a solid position to serve new clients as they pursue new programs with Qualia.

“Craig and Andrew have already proven in a very short time that their experience, knowledge and depth of networking is paying off as we’ve seen a significant increase in Qualia’s outstanding proposals and new contract signings. These new additions will allow us to serve biotech and pharmaceutical companies easily and effectively, in any part of the United States,” said Azhar Kalim, COO, Qualia Clinical Services.

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Qualia Clinical Services Welcomes Steve Peck as Director of Operations

October 21, 2008– Qualia Clinical Services is pleased to announce the addition of Steve Peck, Director of Operations. Steve joins Qualia with 14 years of experience in the CRO industry conducting clinical trials to meet the needs of the global pharmaceutical and biotech industries. Having most recently directed clinical operations for a leading provider of phase 1 contract research, he understands the importance our clients place on defect free execution and on-time performance. Steve will use his knowledge and expertise leading the Qualia operations team to ensure continuous improvement and client satisfaction while maintaining best practices in quality, compliance and efficiencies

“Steve will further strengthen our seasoned phase 1 clinical team while providing them leadership," said COO Azhar Kalim. "Our clients will also greatly benefit from Steve’s hands-on experience and his significant knowledge of the of the early stage business. We are thrilled to have Steve join our clinical team."

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Qualia Clinical Services Chooses ALPHADAS® for Phase I Clinical Trials

Qualia Clinical Services, a highly regarded division of Holmes Biopharma, selects ALPHADAS®, Logos Technologies electronic data capture (EDC) system to streamline and automate clinical trials in its Phase I clinical facility in Omaha, Nebraska.

"Automating our recently expanded Phase I facility with ALPHADAS will enable us to provide our Pharma and Biotech sponsors with top quality, real time access to critical data while conducting state-of-the-art clinical trials," Azhar Kalim, COO of Qualia Clinical Services, Inc.

“We are committed to helping our clients accelerate their time-to-market. We decided to re-evaluate the market because our previous EDC vendor was not meeting our business needs. We chose industry leading ALPHADAS to achieve our operational goals,” Dr. Sohail Khattak, CEO/President and CSO.

Logos Technologies has been providing early phase EDC and clinical site automation tools to the pharmaceutical industry for over 12 years. "We are delighted to welcome Qualia Clinical Services as a new client and value this opportunity to facilitate its operational goals" said Giles Wilson, BEng, co-founder of Logos Technologies. "The partnership will help our mission to become the world’s leading early phase EDC and clinical trial automation company, assisting organizations to reduce the development time of life-saving and life-enhancing drugs.” The rapid success of Qualia's Phase I facility, which opened in the fall of 2006, necessitated the recent addition of 10,000 square feet. The clinic now boasts a total of 33,000 square feet, a bed capacity of over 160 beds and more than 150 professional staff. Additionally, administrative, operational and recreational areas were completely redesigned to better serve clients and study participants. Qualia Clinical Services, is changing lives for the better by providing its partners in the clinical research industry the full capabilities to complete early and late phase clinical trials. A full service contract research organization, Qualia has state-of-the-art clinical operations in Omaha, Nebraska , Toronto, Canada and Kiev, Ukraine. More information about Qualia can be obtained through its website at www.qualiaclinical.com

Logos Technologies is a leading provider of world-class integrated clinical trial solutions to the world’s pharmaceutical, biotechnology and clinical research organisations. ALPHADAS is a clinical study management and fully mobile early Phase proactive EDC system that has been designed for real time eSource data collection. The system provides time based data entry at the bedside, collection and integration of laboratory data, images and scans and Bar-coded labeling to track samples from draw to dispatch. Logos Technologies established and proven product ALPHADAS sets the standard in collecting early Phase clinical trial data. ALPHADAS is fully compliant with industry standards and guidelines including FDA 21 CFR Part 11. More information about Logos Technologies can be obtained through its website at www.logostechnologies.com

For more information contact
Logos Technologies Ltd - Angela King Qualia Clinical Services – Azhar Kalim
Angela.king@logostechnologies.com Akalim@qualiaclinical.com

www.logostechnologies.com www.qualiaclinical.com

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Qualia Clinical Services Business Development Team Grows to Supplement Sales Activity

August 18, 2008– Qualia Clinical Services, a full service Contract Research Organization, is pleased to welcome two seasoned representatives to their Business Development Team.

Craig Miller, Director of Business Development, joined Qualia with an extensive background consulting with biotech and pharma companies through all phases of clinical development in diverse therapeutic areas. Craig gained insight into Phase I selling through working for eResearch Technology, where he sold cardiac safety studies, with emphasis on Thorough QT initiatives. He brings to Qualia a very consultative approach in clinical research based on his knowledge of drug development, ICH and FDA guidelines. Craig will primarily serve East Coast clients out of the Philadelphia office.

“I am delighted to have Craig Miller join our team. He is very experienced and will provide superior knowledge and understanding of the drug development process to our clients,” said CEO Dr. Sohail Khattak.

Kyle Schroeder also joins the team in the new position of Internal Sales Coordinator. Through market research, he will seek new opportunities to assist clients with their upcoming drug development programs. Kyle brings years of client service, sales and marketing experience to the team and will also play an important role of ensuring client satisfaction before, during and after a project is completed.

“We are growing with the industry to best accommodate our client’s needs in a way that’s catered to them,” said COO Azhar Kalim, who leads Qualia’s business development team. Azhar added “Craig and Kyle will help us keep up and best serve our new clients while providing excellent service to our exiting clients. We plan to add three more business development representatives within the next six months.”

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Qualia Adds Controller to Financial Team

August 6, 2008 - Qualia Clinical Services announces the addition of Dale Gray as the new Controller.

“A experienced financial expert is very important to any successful company in the early stages of growth,” said Managing Director John Metcalfe. “We are very pleased to have a qualified individual join our staff.”

Dale has been Controller for over 20 years in several industries. He has extensive knowledge and experience in cost and project accounting along with financial reporting. Dale also brings Qualia much experience working with operations personnel to improve processes and control costs.

Since beginning in April, Dale has led Qualia through many initiatives, including implementation of enhanced accounting systems and processes. These systems are crucial as Qualia undergoes significant growth in its early and late stage business globally.

“Dale has already proven to play an effective role in making key decisions that will allow Qualia to continue to grow efficiently and effectively,” said Dr. Sohail Khattak, President & CEO, Qualia Clinical Services.

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Qualia Clinical Services Expands Services into Europe

July 30, 2008 - Qualia Clinical Services now offers full-scale Phase I-IV clinical trial support to companies interested in conducting clinical trials in Ukraine and Central Europe. Since their site opened in Kiev, Ukraine earlier this year, they have several projects underway, with many more approaching in 2008.

This new division in Eastern Europe is ideal for providing clients immediate access to drug naïve patients with medical conditions that can be very difficult to find in other areas of the world. These include Diabetes, Oncology, Hepatitis C, HIV+, Hepatic & Renal Failure, GI Disorders, and many more.

Qualia maintains a unique database of investigational sites in Ukraine and Central Europe, where they have developed extensive professional and personal relationships with highly qualified teams experienced in ICH-GCP compliant studies across various therapeutic areas. “We ensure the integrity of clinical trials by selecting investigators experienced in conducting industry-sponsored GCP compliant clinical trials,” said Dr. Sergiy Pakharyna, Medical Director.

Clients can choose to outsource only a part of management of the clinical trials or can utilize Qualia’s proven network of facilities and partnerships to effectively complete nearly every aspect of the clinical research process.
“Eastern Europe is one of the most dynamic and fastest-growing regions in Europe, and there are several advantages to placing clinical research studies in these areas: large population, centralized healthcare system with developed referral network, good selection of high-quality investigational sites, availability of patients, and superior quality of clinical data confirmed by audits and inspections,” stated Sohail Khattak MD., FRCP(C) President/CEO,Qualia Clinical Services.

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Azhar Kalim promoted to Chief Operating Officer

Qualia is pleased to announce a change in the executive management structure. The company has promoted a founding member of the management team into a new roles within the company. Azhar Kalim advances into the role of Chief Operating Officer. Mr. Kalim will be responsible for Qualia’s worldwide operations. This promotion comes as a result of the leadership that Mr. Kalim demonstrated during the last 19 months as Qualia’s General Manager and Vice President of Business Development.

“Azhar has provided infinite energy, wisdom and leadership above and beyond what is required,” states Qualia Chief Executive Officer, Dr. Sohail Khattak. “I cannot think of a better individual to take over this position than Azhar. Our overall sales performance has consistently exceeded expectations under Azhar’s leadership. But his contributions to Qualia go well beyond just managing the Business Development team, he has in many ways been the guiding light for this company. I anticipate that he will continue to create an environment of success in this new capacity.”

“I look forward to working with our very capable management team here at Qualia to continue our growth,” Mr. Kalim states. “I will also work to enhance our cohesive global operations to maximize quality and timeliness. I want to ensure that each and every client has a premium experience with Qualia.”

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Qualia and MedXView Partner to Provide eCTD Submissions

(November 9, 2007) Qualia Clinical Services and MedXView have entered a partnership to provide eCTD submissions for clients. By partnering with the industry leader in electronic submissions solutions, Qualia becomes a premier resource for clients who need to perform electronic submissions to the FDA either currently or in the future.

The eCTD is defined as an interface for industry to agency transfer of regulatory information, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management, and archival of the electronic submission. Making a valid eCTD submission without a tool is time consuming and error prone. These potential delays and errors can cause companies to incur costs and limit their competitive advantage. The Qualia and MedXView partnership for eCTD submissions insures fast and accurate eCTD submissions according to the federally mandated guidelines.

Qualia President & CEO Dr. Sohail Khattak explains how this partnership will impact Qualia’s clients. “Every decision we make as a company is absolutely focused on providing benefits to our clients. The MedXView partnership delivers innovative tools to our clients that provide reliable and user friendly solutions for data transfer. Our generics clients will especially benefit in the shot term from this partnership because they are currently required to electronically submit data for all abbreviated new drug applications (ANDA).”

“The MedXView system is proven, easy to use, and secure,” says MedXView Head of Business Development, Peter Rais. “There are drag and drop features, easy to read menus, and a simple interface for locating files. Much of our system is automated and there is a built-in validation tool. We are able to help users become more efficient and finish projects faster. Our experience in this field goes back since our background is in regulatory consulting. Our software solutions are tailored specifically for the needs of Qualia’s clients and everyone can expect improved efficiencies.”

The Qualia implementation strategy is underway, and clients can expect to have access to the MedXView early in 2008.

Learn more about MedXView.

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New Clinical Study Managers Enhance Growing Department

(November 6, 2007) Qualia Clinical Services continues to grow and is expanding the operational team to effectively manage the increasing capacity. Two new Clinical Study Managers are joining Qualia.

Yishun Lin, MD has four years of experience as a Clinical Research Coordinator, working with patients in a hospital setting. He most recently worked for Alegent Health Research in Omaha, NE, and previously for Temple University in Philadelphia working with radiation oncology studies. Yishun has a medical background and is a ACRP certified Clinical Research Coordinator. Yishun is motivated to contribute to the growth of select population studies at Qualia.

Damien Foster comes to Qualia from a successful instrumentation and bioanalytical company in Omaha, NE. He helped start the Clinical Services department of the company, and as Associate Lab Manager he contributed significantly to the growth of the company. He also performed field technical support, working extensively with all levels of contacts at client organizations. He feels that the sense of ownership he developed will help him manage Qualia studies with an approach that clients will appreciate.

Qualia is focused on delivery clients premium service, and therefore one of the most critical positions at Qualia is that of Study Manager. “We have created a system that encourages personalized interactions between our Study Managers and our clients,” explains Mark Slama, Director of Operations and all of Qualia.

“We understand that this industry is very detail oriented, which requires a certain profile for managers. But additionally we see that our clients each have a need for customized solutions to their study challenges. We seek Study Managers that have diverse backgrounds and excel at critical thinking and problem solving, who can build relationships with clients in order to effectively respond to needs and challenges.”

Both Yishun and Damien will transition into the department through an extensive training program overseen by operations management in association with the Quality Assurance department. “We are lucky to have the luxury of recruiting such talented employees,” explains Mark Slama. “Their experiences and attributes help us continue to improve our effectiveness and responsiveness for our clients.”

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Qualia Clinical Services Enhances Data Management Team

(October 1, 2007) Qualia Clinical Services is pleased to announce the addition of Arold Davilmar to the management group. Mr. Davilmar joins Qualia as the Manager of Biostatistics for the rapidly growing Data Management team. Located in Qualia’s Toronto, Canada offices, the Data Management Team works to ensure accurate, secure and timely delivery of testing results to our clients.

Mr. Davilmar possesses considerable experience in applied health research, and possesses a profound understanding of data integrity and database design. His expertise in statistical analyses, interpretation and presentation of results, along with his vast knowledge of data analysis and clinical trial management is an invaluable addition to Qualia.

In his career, he has provided consulting and data analysis expertise for several highly regarded institutions such as Princess Margaret Hospital, Queen’s University, Toronto General Hospital and the biopharmaceutical industry.

Dr. Sohail Khattak, President/CEO of Qualia Clinical Services, said, “ Mr. Davilmar will make a meaningful contribution to the service Qualia can provide clients. “Effective data management is very important to our clients. The addition of Mr. Davilmar to Qualia significantly reinforces our commitment to continuously enhancing the data management element of our business. As this department expands and improves, we will continue to become a more valuable and trusted partner for our clients.”

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Qualia Expands Phase I Facility

(September 17, 2007) Qualia Clinical Services Inc. is pleased to announce the expansion of Omaha’s Phase 1 facility. Since opening our doors in the fall of 2006 we have had to add an additional 10,000 square feet of clinic and administrative space. This now brings the total square footage to 33,000. Our administrative, operational and recreational areas have been completely redesigned to provide increased bed capacity and resulting flexibility to service our clients and our study participants even better. We are also proud to say that Qualia’s team of dedicated professionals is now approaching 120 and standing by to provide uncompromised service of the highest quality at a moments notice.

Due to our rapid success in such a short period of time and the increasing demand for Phase 1 studies, we are also making plans for additional clinics in other domestic and international locations.

We would also like to take this opportunity to thank our valued and loyal clients for having the trust in Qualia to be one of their service providers of choice.

This growth and expansion is a testament of the faith that our sponsors and clients have placed in us and we are committed to quality of service and research we provide in return, said Azhar Kalim, Vice President and General Manager.

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Qualia Welcomes Dawn McCollough as Director of QA, Regulatory Affairs & Training

(September 10, 2007) Qualia Clinical Services is extremely pleased to announce that Dawn McCollough has joined the Team Qualia as Director of QA, Regulatory Affairs and Training.

McCollough brings Qualia a wealth of knowledge, with over 13 years of experience in the Pharmaceutical, Biotech & CRO industries.

McCollough has extensive Global Project Management, Clinical Operations and Regulatory Affairs experience. She has developed global clinical trial development programs, including clinical operations, project management, IND/NDA planning/submissions and life-cycle management. Her background is in a wide variety of therapeutic areas including CNS, Dermatology, Respiratory, Endocrinology, Musculoskelatal, Nephrology, Transplant, Urology, rare genetic disorders and Device studies in Phases I-IV.

McCollough's considerable Phase I experience includes patient studies with a PK component, Food Effect, SAD, MAD, Mass Excretion/Mass Balance, Radio Assay, Assimilation studies, high fat and kinetic marker studies. She began her career as a Study Coordinator for a Phase I unit that performed NIH as well as Pharmaceutical studies and most recently worked for four years within a Pharmacology division of a major Pharmaceutical company where she was charged with responsibility for complete site management of sites that were performing Pharmacology trials.

McCollough has won multiple industry awards for superior achievement in Project Management and Clinical Operations, including an award granted to only 2.5% of employees within a major Pharmaceutical company per year, based upon her superior performance and contribution.

“The addition of someone of Dawn’s caliber to our team is a testament of the value and importance we place on regulatory and training elements in the phase 1 industry. Doing things right the first time is key to our and our clients’ success and Dawn can help us ensure that.”, said Dr. Sohail Khattak, CEO and President of Qualia Clinical Services.

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Qualia Continues to Strengthen its Quality Control Team

(July 2007 - September 2007) Qualia Clinical Services is pleased to announce two new additions to our Quality Control team. Julie and Sarah will provie further audit support of our processes and data to guarantee accuracy and integrity.

Julie Marvin started as a Quality Control Specialist on July 16th. She has a Bachelor’s degree in Biotechnology with a Chemistry Minor and a Master’s degree in Immunology and Microbial Pathogeneses. She has directed studies in immunology, virology, cell biology, and transplantation-based research for over 7 years. In addition, she worked for a CRO to direct pre-clinical cell and viral based assays in compliance with GLP, GMP, CFR, and/or PTC, and SOPs. Further, she worked for a major CRO to initiate appropriate investigational sites for clinical studies in order to ensure that studies are carried out according to study protocol, SOPs, applicable regulations and GCPs.

Sarah Piskorski joined Qualia as a Quality Control Specialist on September 5th. Sarah brings over six years of experience working in the CRO industry, most recently as a Quality Assurance Auditor for a leading CRO where she was responsible for auditing laboratory and method validation data and writing and reviewing SOPS including quality policies and procedures. She also brings experience in regulatory training in the GLP environment, as well as laboratory experience and training.

Julie and Sarah are responsible for the review and coordination of regulatory functions within Qualia Clinical Services Quality System, ensuring compliance with FDA and other regulatory requirements. Areas of responsibility include data review, process support, Quality Control functions, auditing, process improvement implementation and training for other personnel in the requirements of the Quality System and relevant standards and regulations.

"Julie and Sarah both bring diverse experience to the table, which will allow us to continue to advance our processes to the next level", Mark Lewallen, Quality Assurance Manager.

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New Study Managers Join Growing Team Qualia

(June 2007 - September 2007) Qualia Clinical Services is proud to announce the addition of two new Clinical Study Managers to serve our clients, who combined add over 16 years of Phase I experience to our team.

Kim Grotheer brings over five years experience in conducting Phase I-IV clinical trials, with broad based knowledge in the areas of Oncology, Endocrinology, Rheumatology and Neurology.

Keila Harbour-Marik offers Qualia two years of experience in pre-clinical research, four years experience with project management, and seven years of experience in the veterinary medicine field. In addition to project management, Keila's past experience has prepared her for responsibilities in a variety of areas including purchasing, QA, and lab pracitices.

"We are excited to put the experience of these dedicated managers to work for our clients. These new additions will allow us to stay ahead of our rapid growth so that we may deliver superior service to our clients, " Azhar Kalim, Vice President and General Manager.

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New Addition to Qualia's Quality Assurance Team

(May 21, 2007) Qualia is pleased to announce the addition of Shon Logue to Qualia Clinical Services as a Quality Control Specialist. Shon brings with him a background that includes a Cell and Molecular Biology degree from Missouri State University, and over eight years of hands-on experience in the Contract Research Organization industry. He most recently served as a Validation and Bioanalytical Scientist at a major CRO.

Shon’s role at Qualia will involve streamlining processes and ensuring compliance with IRB, FDA, ICH and company SOPs. “Shon’s bioanalytical background is very useful in our efforts to incorporate improvements into existing systems of clinical operation. His expertise has had an immediate and positive impact on our processes. We look forward to working with Shon, and appreciate his efforts to ensure quality results that both we and our clients expect” said Mark Lewallen, Quality Assurance Manager, Qualia Clinical Services. Shon is committed to help Qualia refine and fine tune the level of quality we provide to our clients as our business continues to show strong growth.

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Qualia Pampers Local Women in Support of Women's Health Week

(May 20, 2007) In celebration of National Women’s Health Week, Qualia Clinical Services pampered over 100 local women.

The event held on Sunday, May 20 and Monday, May 21 included free lunch, chair massages, mini manicures and mini pedicures. The staff also provided free health tests, including blood pressure, diabetes and body mass index. Each women took home a free gift and information, and three lucky guests took home a spa package from Faces Spa. Guests also were given the opportunity to speak to Qualia's Executive & Medical Director Dr. Robert Schwab, as well as local OBGYNs, Kay Thatcher and Shawn McFadden.

“It’s natural for Qualia to support National Women’s Health Week,” says Qualia Vice President and General Manager. “And our event, “Pampering your Body, Mind and Spirit” will encourage women to take some simple steps towards a healthier and happy life.”

In addition to the day of pampering, the women tour the state-of-the-art facility, designed for the comfort of Qualia’s study participants. They also learn about clinical trials and how resulting new medical treatments contribute to enhanced quality of life and benefit a wide variety of people. The event highlighted opportunities in which the women can not only make a positive difference, but also earn money for their participation. Participation stipends range from $500 to nearly $6,000.

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Qualia Welcomes HR Manager

(May 14, 2007) Sherry Trupp has joined Team Qualia to support our growth and to continue and improve on the quality of care and attention provided to Qualia employees.

Sherry comes to Qualia with over 20 years of experience in Human Resources. She earned her PHR (Professional in Human Resources) in 1999 and earned her GCDF (Global Career Development Facilitator) in 2005. Prior to coming to Qualia Clinical Services she was the Regional Human Resource Manager for AmSan Nogg Chemical and Paper for approximately thirteen years.

Sherry’s role will involve managing the day-to-day operations of the human resources, developing and implementing personnel policies, employee appraisals, hiring of new team members, and much more.

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Qualia Clinical Adds Marketing Manager to its Team

(February 13, 2007) Holly Baker has joined Qualia Clinical Services as Manager of Marketing. Holly's role will involve managing the development and use of the company brand, coordinating corporate marketing initiatives, organizing trade shows, and supporting the needs of our business development team. She will also provide support for Qualia's recruiting efforts.

Holly brings Qualia over five years of consumer and business marketing experience, most recently from GiftCertificates.com, an Omaha based provider of incentive solutions. With GiftCertificates.com, she was
responsible for organizing corporate trade show efforts and managing multiple integrated campaigns, utilizing
both online and offline channels.

"This recent appointment will strengthen Qualia’s business development team and their efforts, as Holly's
efforts will directly build on the level of service we provide to our clients and better understand their needs",
said Azhar Kalim, Vice President and General Manager, Qualia Clinical Services.

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Qualia Clinical Services Chooses Omaha over Several Other Major US Cities

(November 16, 2006) – Omaha’s first early phase clinical research facility is just opening its doors to the community, but it’s already working towards solutions and potential cures to some of our most pressing medical challenges.

Qualia Clinical Services’ new, 23,000-square foot clinical research facility at 10845 Harney St. is designed for Phase I trials of drugs which will tackle conditions and diseases such as hypertension, Alzheimer’s, rheumatoid arthritis, HIV and many others. Seven drug studies are already underway and nearly $4 million in active proposals are pending.

Omaha was chosen for the research facility over a number of cities, including Phoenix, Houston, Indianapolis, Baltimore and Reno. Leaders of the contract research organization (CRO) say a vibrant research community and access to reliable healthy study participants is crucial for clinical trials, and Omaha was the logical choice.

In addition to the new facility, Qualia’s nearly $4 million investment has attracted a leadership team with 75 combined years in the pharmaceutical research industry.

The growing demand for outsourced clinical studies provided by quality CRO's is tremendous, says Qualia’s President & CEO Dr. Sohail Khattak. “there are currently over 23,000 potential new drugs in different stages of development and Qualia will get a chance to work with many of them”

Greater Omaha Chamber CEO & President David Brown said Qualia’s decision to locate in Omaha will result in new business from leading biopharmaceutical companies, not only from across the country but internationally as well. “Qualia’s partnership with these companies is a real plus for Omaha and the State of Nebraska,” he said. “The word is out that our research community and business climate have much to offer.”

Clinical trials utilize human volunteers in order to evaluate the safety & efficacy of new drugs in development. Clinical research provides the fastest way to improve human health by developing treatments for illnesses and ailments which impact everyday quality of life. The Omaha facility is customized for Phase I clinical trials that will provide the foundation for the development of new, lifesaving drugs.

At today’s opening, the Qualia’s leadership team showcased a state-of-the-art, 160-bed facility equipped with a sample processing laboratory, special procedures unit, four participant dormitories, a screening center, call center, patient recreation areas and full-service dining room. Today’s new drugs must be carefully evaluated for their impact on the human heart. The facility was specially designed for cardiac safety studies, and is equipped for 24/7 real-time cardiac monitoring.

“Qualia’s approach to research is dynamic and adaptive. We are committed to the highest standard of responsiveness and service to our clients,” says General Manager and Vice President, Business Development Azhar Kalim. “Our approach is flexible, innovative and focused on our clients’ needs. Our clients are responding very well to this approach.”

The length of clinical studies can vary from two to ten days and study participants receive stipends for their time. Qualia anticipates stipend payments in excess of $3 million dollars in 2007.

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Qualia Clinical Services and Tandem Labs Form a Strategic Partnership to Provide Streamlined Clinical Research Services

(October 24, 2006) Qualia Clinical Services, a leading provider of Phase I-IV clinical research, and Tandem Labs, a premier bioanalytical and immuoanaltyical testing laboratory, announced their strategic alliance today. This partnership creates a compelling value proposition for the pharmaceutical, biotechnology,and generic industries by providing access to streamlined drug development services with an unprecedented emphasis on quality and efficiency.

The combined force of Qualia and Tandem offers clients access to the complete suite of services related to clinical research. As a result of the alliance, clients can expect to:

Achieve synchronized scheduling — minimize “downtime” between clinical completion and sample transfer for bioanalysis
Effectively utilize the companies as one resource, from signing one agreement to the
receipt of an integrated and customized report
Maintain a single point-of-contact providing consistent oversight throughout all aspects of the project.

“The need for accurate data delivered in a timely fashion is critical to our clients. Through our alliance with Tandem Labs, Qualia now has access to one of the leading bioanalytical laboratories. Their core values are aligned with ours — both companies are client focused and have a passion for quality. The foundation of combined industry experience is quite impressive,” said Sohail Khattak, MD, FRCP(C), president and CEO of Qualia. “Additionally from a geographic standpoint, we are perfectly equipped to serve our clients’ needs for a completely integrated approach. Qualia’s main clinic is located in the middle of the United States while Tandem has facilities on the East and West Coasts. These are truly exciting times not only for our company, but also for the clients we serve.”

“This alliance gives us the unique opportunity to partner with another CRO that provides
exceptional customer care combined with scientific expertise,” said Denis Lin, Ph.D., president and CEO of Tandem Labs. “It is a true partnership: Qualia’s strong clinical research foundation combined with Tandem’s scientific knowledge, low-risk approach, and technologies.”

About Tandem Labs
Tandem Labs is a leading bioanalytical contract research organization (CRO) specializing in advanced mass spectrometry and immunoanalytical support as well as pharmacokinetics and pharmacodynamics (PK/PD) for the pharmaceutical and biopharmaceutical industries in the United States and internationally. Bioanalytical service offerings include rapid method development of LC/MS/MS and GC/MS/MS assays to support clinical and pre-clinical studies adhering to Good Laboratory Practices (GLP) as well as discovery work specializing in rapid development, abbreviated validations, and high-throughput analysis of non-GLP samples. Immunoanalytical services include method development, validation, and sample analysis fornovel and esoteric biomarkers as well as the analysis of biotherapeutics and antibodies. PK and PD services use DMDiscoverySM and MarkerScanSM, proprietary informatics used for metabolite profiling, identification, and quantification; biomarker discovery and screening; protein-bindingassays; and discovery bioanalytical support services. With this comprehensive suite of services, Tandem’s mission is to help clients reduce their overall time in bringing new medicines to market using a disciplined, low-risk approach. Detailed information about the company is available at tandemlabs.com.

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Qualia Continues to Add Industry Expertise With the Appointment of Jim Cunningham

(September 14, 2006) Qualia Clinical Services, a contract research organization (CRO), announces the appointment of Jim Cunningham as director of recruiting for its Omaha, NE clinical research facility. Cunningham will directly manage the study participant recruiting efforts at the Omaha clinic, including management of all recruiting and call center staff and development of the participant database, call center and screening facility. He will also focus on developing and maintaining relationships within the local healthcare community.

“We are thrilled to have Jim join our management team,” said Azhar Kalim, vice president and general manager. “He brings a wealth of study participant recruitment experience and with Jim’s management skills, Qualia is able to provide clients with access to an extensive database of study participants for rapid study initiation. He is one of the best in the CRO industry.”

Cunningham has over six years of professional experience within the CRO industry—all focused on physician relations and participant recruitment. During this time he has been responsible for successfully establishing new recruiting operations on the East coast and realigning recruiting operations in the Midwest.

He joins a team of seasoned professionals including Sohail Khattak, MD, FRCP(C), president and CEO; Azhar Kalim, vice president and general manager; John Metcalfe, chief financial officer; Robert Schwab, MD, principal investigator; and Mark McDonald, executive director of operations.

Earlier this year, Qualia announced the opening of its 160-bed, 23,000 sq ft, state-of-the art facility based in Omaha, NE.

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Qualia Clinical Services Announces the Appointment of Azhar Kalim as Vice President, Business Development and General Manager

(September 13, 2006) Qualia Clinical Services, a contract research organization (CRO), announces the appointment of Azhar Kalim as vice president, business development and general manager of its North American clinical operations. He is responsible for leading the business development activities of Qualia which includes building client relationships, development of strategic partnerships and implementing strategies for North American growth.

Kalim has an extensive and impressive background in the clinical research industry, with over 16 years of experience. He held pivotal roles during his tenure, including scientific oversight as a principal scientist and as a member of the business development team managing a significant portfolio of major biopharmaceutical clients. Prior to joining Qualia, Azhar served as vice president, business development at BA Research International.

“Azhar possesses a unique professional combination of skills: seasoned scientific knowledge along with refined sales experience,” said Sohail Khattak, MD, FRCP(C), president and CEO. “With his remarkable background developing client relationships and his strong management skills, he will contribute significantly to the success of Qualia.”

Kalim is a member of various professional associations, including American Association of Pharmaceutical Scientists, Drug Information Association and American Society of Mass Spectrometry.

Earlier this year, Qualia announced the opening of its 160-bed, 23,000 sq ft, state-of-the-art facility based in Omaha, NE.

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Qualia Clinical Services Announces the Opening of its Omaha NE Facility

(September 12, 2006) Qualia Clinical Services, a contract research organization (CRO), announces the opening of its 160-bed, 23,000 sq ft clinical research facility in Omaha, Nebraska for the conduct of studies in healthy volunteers and special patient populations. The state-of-the-art facility includes a Phase I clinic (22 hospital beds), five bioavailability/bioequivalence dorms, separate participant recruitment area, on-site sample processing laboratory, treatment rooms, kitchen, dining room, physicians’ offices, controlled-access pharmacy, wireless access throughout the facility and secured drug storage room along with administrative offices.

Sohail Khattak, MD, FRCP(C), founded Qualia Clinical Services based on his extensive background as a Principal Investigator and manager of Phase I-IV clinical trials. Dr. Khattak serves on several scientific advisory boards of major pharmaceutical companies and has formed an impressive medical advisory board at Qualia. The medical advisory board is chaired by Mohammed Quader, MD, and focuses on the quality of clinical research while providing the senior management team with access to the latest and most accurate medical information.

“We have a strong foundation and are poised to be a global leader in the contract clinical research arena,” said Sohail Khattak, MD, FRCP(C), president and CEO, Qualia. “The technologies of Qualia combined with our experience ensure the rapid implementation and completion of projects.”

The senior management team at Qualia (Omaha) combines over 75 years of experience in the CRO industry. Azhar Kalim serves as vice president, business development and general manager of North American clinical operations. He has over 16 years of experience in the CRO industry, serving in the vital oversight roles of strategic growth of the company and business development initiatives. Mark McDonald, executive director of operations, heads the clinical operations team. With over 15 years of phase I clinical research experience, his background includes extensive expertise in the organization of clinical operations and client relationship development. Jim Cunningham, director of recruiting, has been establishing successful recruitment operations in the Midwest for the past six years and is one of the best in the industry. Robert Schwab, MD, serves as principal investigator. Prior to joining Qualia, Dr. Schwab was the medical director for the ambulatory clinics of University of Nebraska Medical Center (UNMC) Physicians. He is board certified in internal medicine and has been named one of Omaha’s top physicians from 2002-2005.

The facility is staffed with a highly trained and dedicated contingent of clinical professionals having focused expertise in Phase I clinical research. Some of the top ten pharmaceutical companies have performed audits of the facility and have been extremely impressed with breadth of experience of Qualia’s staff and the state-of-the-art facility.

“The opening of our clinical research facility in Omaha, combined with our world-class scientific expertise and exceptional customer care, marks our ability to be a unique partner to the pharmaceutical, generic and biotechnology industries,” said Azhar Kalim, vice president and general manager. “Qualia is dedicated to redefining clinical research services in terms of quality—applying strategic thought to each project, anticipating client needs, delivering accurate results—and quantity, with a solid database of study participants readily available for clinical trials.”

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Qualia Clinical Services is changing lives for the better by providing its partners in the biopharmaceutical industry the full research capabilities to complete early and late phase clinical trials. A contract research organization (CRO), Qualia has state-of- the- art clinical operations in Omaha, Nebraska, Toronto, Canada and Kiev, Ukraine. Qualia is fully equipped to conduct cardiac safety studies and offers advanced cardiac monitoring. Qualia, headquartered in Scottsdale, Ariz. is a subsidiary of Holmes BioPharma Inc. To find out more about Qualia, contact Azhar Kalim, General Manager and Vice President, Business Development at akalim@qualiaclinical.com or (402) 697-6520.