CRO Industry News

Bioanalytical Systems, Inc. (Nasdaq: BASI) (BASi) announced today that revenue for the third quarter of fiscal 2011 ended June 30, 2011 increased 5.1% to $8,478,000 from $8,064,000 for the third quarter of fiscal 2010.

Dermal toxicity experts at Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, led a webinar discussing the topic, „Dermal Toxicity Study Design and Methodology.‟ The interactive discussion covered the challenges facing effective study design and execution.

The webinar discussed the implications for animal welfare, as well as current study designs and techniques used for dermal studies. During the webinar, Ricerca shared its experience with the use of behavioral conditioning using enhanced food rewards as a means of significantly reducing animal handling and stress during dermal dosing as part of its ongoing animal welfare program.

Topics covered during the June 23, 2011, live webinar included:
  • Dermal and photo toxicity and other routes of administration for improving systematic exposure
  • Histopathology/skin structure and choice of species
  • Regulations and what is required for these types of products
“Ricerca has invested heavily in its people, facilities and equipment to become the leader in dermal toxicology,” commented Ian Lennox, CEO of Ricerca. “We are proud to present this webinar and share our expertise with the industry.”
Ricerca Biosciences provides a full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability.

About Ricerca Biosciences
Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.
CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry, announced that the Company’s revenues for the six month period ending June 30, 2011 more than doubled from the same period in 2010, while earnings showed an even larger percentage increase over the prior period. CRF Health has now consistently generated earnings over the last ten consecutive quarters. CRF Health also added more than 15 new sponsor or CRO relationships while retaining 100% of its key account client base during that time.

“We’re excited to show continued strong financial performance with revenue more than doubling and profits up even more,” said Rachael King, Chief Executive Officer. “Our financial success allows us the freedom to continue focusing on customer service and expanding our technology offerings.”

Jeffrey S. Payne, Chief Financial Officer, commented, “Sponsors need to know not only that they can trust a partner with their data, but that their partner is financially stable and will be there in the future. Our continued strong financial results validate that Sponsors can trust CRF Health to be there in the future, while our growth in revenue evidences Sponsor’s recognition of the quality services we provide. CRF Health is proud to continue on its path of outstanding customer support as well as consistent profitability.”

About CRF Health
CRF Health is a global leader in ePRO (electronic patient reported outcomes) solutions for the life sciences industry. Through innovative technology, a thorough understanding of drug development, and mobile computing, CRF Health is driving the change to higher quality outcomes and more efficient paper-free clinical trials.

CRF Health’s ePRO technology has been used in more than 70 countries, on six continents and 68 regional languages, including several regional Indian dialects. CRF Health consistently demonstrates the industry’s highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.

Since its founding in 2000, CRF Health continues to provide true global ePRO delivery and service. Headquartered in the US, CRF Health operates its R&D center of excellence in Helsinki, Finland and has offices around the world.

For more information, please visit www.crfhealth.com.

PRA, a leading Clinical Research Organization, announces that the third edition of respiratory care expert Jack Wanger’s book, Pulmonary Function Testing: A Practical Approach, has recently been published by Jones & Bartlett Learning in Sudbury, MA.

Comprehensive Clinical Development, a clinical services company delivering high-quality clinical trials from Phase I-IV with three pharmacology units and five patient-focused centers, is pleased to announce the expansion of the Company with the relocation to its corporate headquarters in Miramar, Florida.

The new Miramar, Florida, facility will enable further expansion for the Company’s future growth. Comprehensive has also recently expanded its operational capacity in Tacoma, Washington, with 250 beds. This clinic not only increases capacity for clinical conduct, but broadens access to special populations including oncology and the capability to conduct radiolabeled studies.

“Relocating our corporate headquarters represents an investment in our future,” stated Comprehensive CEO Jack McGovern. “We are extremely pleased at the rate Comprehensive is succeeding in this difficult economy and the confidence our clients have in Comprehensive. We are committed to continuing our commitment to quality delivery of clinical development services from our new headquarters. This is another step toward extending our clinical research services, therapeutic areas and customer relationships.”

Comprehensive is known in the industry for delivering quality results on time and within budget. In a recent independent study, Comprehensive received a 100% client satisfaction rating along with a high quality rating. Comprehensive offers distinct capabilities in clinical research that keep trials and drug development on the fast track from initial concept to market, without sacrificing quality or integrity. Since its inception, Comprehensive has earned its reputation for reliability and surpassing expectations.

About Comprehensive Clinical Development

Comprehensive Clinical Development is a strategic clinical research partner providing a full range of clinical services in various therapeutic areas with an outstanding record for consistently delivering quality and success on time and within budget. Comprehensive holds a solid track record of collecting early efficacy data across various patient populations, and offers distinct capabilities in clinical research. For more information about Comprehensive, visit www.ComprehensiveCD.com.
ACR Image Metrix™, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to welcome Kathy Freeman as the Business Development Manager for the East Coast.

Freeman has extensive experience in sales strategies, team leadership and new market development, providing her the background and skills necessary to perform as a high caliber teammate focused on client relationship in the CRO and medical device industry.

Prior to joining ACR Image Metrix, Freeman held several key positions within niche CRO organizations, where she created a strong presence and landed numerous contracts in the pharmaceutical and biotech market. Freeman began her career on the specialty pharmaceutical side in sales and grew a regional company to a national organization while managing a sales team of 35 people.

Freeman holds a Bachelor of Science degree from LaSalle University and a nursing diploma from Abington School of Nursing. She is an active member of the Drug Information Association (DIA), as well as several biotechnology societies including Pennsylvania Bio, New Jersey Bio, Massachusetts Bio and Mid-Atlantic Bio.

“We are excited to welcome Kathy to our office,” said General Manager of ACR Image Metrix, Michael J. Morales. “She has great strategic sales experience within the CRO industry and will be a huge asset to our team.”

As one of the industry’s leading imaging CROs, ACR Image Metrix specializes in providing imaging CRO services to assist pharmaceutical, biotech and medical device companies around the world.

About ACR Image Metrix
ACR Image Metrix, an imaging contract research organization (CRO) located in the American College of Radiology Clinical Research Center in Philadelphia, applies imaging techniques to improve the efficiency of drug and medical device development programs. The world-class team of radiologists and imaging scientists at ACR Image Metrix work with pharmaceutical, biotech and medical device companies to integrate the appropriate imaging technologies, modalities and clinical design techniques into their imaging studies. ACR Image Metrix has years of experience utilizing state-of-the-art technologies to provide a complete line of imaging services from site qualification and training, study initiation, image management, reader studies and much more.
TKL Research announced today that Kevin Vernarec has assumed the newly created position of Vice President of Operational Excellence.

In this new role, Vernarec will carry the responsibility for ensuring that all clinical research organization (CRO) systems and processes are performed with optimum quality and are executed utilizing appropriately allocated resources. Also, he will assure that the best technology is used in the most cost-efficient means possible.

“Those who have worked with Kevin appreciate the deep experience and vast knowledge he has brought to TKL with new or improved ways of delivering our services,” said Dr. Bob Reardon, Executive Vice President, COO. “The objective of his role is to ensure client satisfaction and continuous operational improvements resulting in exceptional and increasing business relationships.”

Prior to TKL Research, Vernarec held a variety of high-level operations positions for multinational CROs. His breadth of experience covers global project management, clinical operations, proposals, budgeting and costing, CTMS and EDC systems implementation, vendor management, process re-engineering and project planning and tracking. Kevin holds a Bachelor of Science degree in biology from Pennsylvania State University.

About TKL Research
Headquartered in Rochelle Park, New Jersey, TKL Research is a full-service international clinical research organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. TKL Research provides comprehensive clinical trial management services for Phase I-IV clinical research studies, including an inpatient Phase I facility and outpatient specialized research clinics while delivering to our clients a competitive edge with accelerated enrollment.
PRA, a leading Clinical Research Organization, announces the recent creation of a legal entity in Bulgaria to support continued growth and expand operations in the Balkan area. Located in Sofia, the new entity will enhance PRA’s local presence, provide a solid base for growth, and strengthen PRA’s ability to provide professional quality clinical services in Bulgaria and neighboring countries.

PRA began operating in Romania and Greece in 2006, and demand for services in the Balkan region has steadily increased and expanded to Turkey and Bulgaria. PRA's staff has grown accordingly and the number of feasibilities and awarded projects nearly tripled in the past year alone.

“In addition to our presence in the Central and Eastern European region, PRA’s new entity in Bulgaria is a part of our strategic growth and development that clearly demonstrates our commitment to expansion,” said Dr. Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia-Pacific and Africa.

With over 40 offices worldwide, PRA continues to grow and expand into new regions for clinical research. The legal entity in Bulgaria further demonstrates our commitment to meeting the expanding needs of our clients in an ever-changing clinical trials environment and provides our local teams with a local corporate basis for operations.


About PRA

PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.

We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.

To learn more about PRA, please visit praintl.com, email This email address is being protected from spambots. You need JavaScript enabled to view it. or call our Global Headquarters.

Chiltern International Limited (Chiltern), a global clinical contract research organization (CRO), announced that the company has established a new legal entity in Israel.

“Chiltern has experienced a healthy number of requests from our clients in this region and forming a legal entity is a natural progression to our work there,” commented Armand Czaplinski, Chiltern’s Executive Director, Global Country Management, who will be leading the effort in Israel. “Israel is an attractive location to conduct clinical trials as it has many key opinion leaders (KOL) in clinical research and outstanding quality of research. Israel has some of the most skilled and educated work forces with the highest number of doctors, scientists and engineers per capita than any other country. Another key advantage is that the majority of Israel’s population belongs to the same health maintenance organization and this facilitates quick start for clinical trials and reduces the overall project timelines.”

Glenn Kerkhof, Chiltern CEO, stated, “We are delighted to add Israel to our established global footprint to better serve our clients. It is essential for Chiltern to have operations in Israel to tap into the renowned clinical research expertise, experienced investigators and key opinion leaders available in this country.”

About Chiltern:
Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs nearly 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. Further information is available at: www.chiltern.com.
Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce the appointment of Dr. Raymond Farmen as Vice President of Global Bioanalytical Services. Dr. Farmen will have responsibility for the company’s bioanalytical operations in Zurich, Switzerland and Lincoln, Nebraska USA.

Dr. Farmen comes to Celerion with over 30 years of experience in the contract research organization (CRO) and pharmaceutical industries. Prior to joining Celerion, he held executive positions at PharmOptima, a CRO that specializes in ocular research services; Eurofins AvTech Laboratories, a CRO that specializes in small and large molecule bioanalytical chemistry as well as QC testing and analysis of finished drug products and pharmaceutical ingredients; and Camargo Pharmaceutical Services, a CRO that provides scientific and regulatory oversight during the drug development process. Dr. Farmen also held leadership positions in the bioanalytical sciences at MDS Pharma Services, Phoenix International Life Sciences, and Bristol-Myers Squibb.

Dr. Farmen has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GMP regulations. He played a pivotal role at the Crystal City meetings which helped to shape the early regulatory landscape and guidelines for bioanalysis of pharmaceutical products.

“We are very pleased to have Ray on the management team at Celerion,” said Susan Thornton, President and CEO of Celerion. “His in-depth knowledge of drug development, bioanalysis and regulatory strategy from both the client and CRO perspective will be a great asset to our organization.”

Dr. Farmen earned his doctorate in pharmacology from Indiana University and did post-doctoral research in Biochemistry at the Upstate Medical Center in Syracuse, New York.

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Want more? Visit...

Videos

  • ICON- Partnerships 12
    ICON- Partnerships 12 Steven Cutler, Group President of ICON discusses the launch of ICON's new acquisition of Firecrest at Partnerships in Clinical Trials 2012. Facing the continuing challenge of not only monitoring and…
    Read more...
  • ICON- Partnerships 12
    ICON- Partnerships 12 Steven Cutler, Group President of ICON discusses their exciting new partnership with Roche at Partnerships In Clinical Trials 2012. Medical imaging has always been a strong department within ICON. ICON…
    Read more...
  • ERT- Partnerships 12
    ERT- Partnerships 12 John Blakely, Executive Vice President and Chief Commercial Officer for ERT discusses the new trend in clinical research at Partnerships in Clinical Trials 2012 - the melding of objective and…
    Read more...
  • Chiltern- Partnerships 12
    Chiltern- Partnerships 12 Marcelo Piccirillo, Senior Clinical Research Physician for Chiltern, discusses new trends in gastrointestinal clinical development at Partnerships in Clinical Trials 2012. Current hot spots for clinical development in the field…
    Read more...
  • Blinded Diagnostics - Partnerships 12
    Blinded Diagnostics - Partnerships 12 Paul Savuto, President and CFO, and Steven Karrupan, CEO, from Blinded Diagnostics discuss Point of Care Technology at Partnerships in Clinical Trials 2012. Point of care (or decentralized testing) offers…
    Read more...
  • American Airlines - IQPC 2011
    American Airlines - IQPC 2011 American Airlines has globally launched a passive solutions that gives a new alternative to pharmaceutical manufacturers.
    Read more...

Podcasts