Theorem Clinical Research

Articles Published in 2008

PSI Acquires Latin American CRO Thywill

Monday, August 11, 2008 12:04 PM

St. Petersburg, Russia-based contract research organization (CRO) PSI recently acquired Buenos Aires, Argentina-based CRO Thywill. Financial details of the deal were not disclosed.

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Quest Diagnostics

Covance, Lilly Deal Grows on CRO Industry

Friday, August 8, 2008 05:00 PM

Earlier this week, we reported news about the Covance-Lilly $1.6-billion deal, but has learned additional details about the blockbuster transaction between the contract research organization (CRO) and major pharma company from interviews and Wednesday’s investor conference call.

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Merck's Isentress Results Positive

Friday, August 8, 2008 11:48 AM

Merck reported positive results from an ongoing phase II trial of Isentress for the treatment of HIV. This multi-center, dose-ranging, double-blind, randomized trial enrolled 198 treatment-naïve HIV-infected subjects.

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Parexel's 4Q Revenues Jump 33%

Thursday, August 7, 2008 09:01 AM

Another of the top global contract research organizations (CROs), Parexel reported strong fourth quarter revenues after the bell Wednesday, rising 32.6% to a record $272.2 million compared with $205.2 million in the prior year period.

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Kendle's Global CRO Growth Story Continues with Record Quarter

Thursday, August 7, 2008 07:30 AM

On a day when contract research organization (CRO) Covance announced a blockbuster $1.6 billion deal with Eli Lilly, the global CRO growth story got another big boost when Kendle reported record financial results for its second quarter.

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Covance in Groundbreaking $1.6 Billion Drug Development Services Deal with Eli Lilly

Wednesday, August 6, 2008 09:44 AM

Covance, a leading global contract research organization (CRO), signed a definitive agreement today with Eli Lilly that is designed to help transform Lilly’s R&D model.

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McGoldrick Leaves DIA, Brassington Named Acting Executive Director

Wednesday, August 6, 2008 08:01 AM

Linda McGoldrick, appointed executive director of the Drug Information Association (DIA) earlier this year, has left her position, according to a release on the DIA’s web site.

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QPS Bolsters New Translational Medicine Group

Wednesday, August 6, 2008 07:28 AM

Newark, Del.-based QPS, a provider of research services for the pharmaceutical industry, named Dr. LingSing K. Chen to head its new Translational Medicine department.

“In its Critical Path Initiative, the FDA identified—correctly, we believe—the need for this country to make significant improvements to the process under which new drugs are developed,” said Dr. Ben Chien, QPS president and chief executive officer. “By adding a department of Translational Medicine, we hope to play an integral role in the process of moving research discoveries from the laboratory into clinical practice more rapidly.”

Translational medicine is a scientific discipline that refers to the translation of basic research into new therapies for patients.

“The remarkable growth in our biomarkers business areas led us to consider this path,” Dr. Chien said. “QPS considers the creation of a Translational Medicine department pivotal to providing new technologies to support preclinical and clinical drug development worldwide.”

Chien noted that many QPS clients have already formed Translational Medicine units to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials.

Chien said QPS would combine two existing groups, Immunobiomarker and Molecular Biology, to form the new department. Dr. LingSing K. Chen, former executive director of the Molecular Biology group, will head QPS’ new Translational Medicine department.

“Dr. Chen is a founding member of our Molecular Biology group and has established very diverse capabilities within a short period of time,” Chien said. “She is a determined leader with a great deal of entrepreneurial spirit and I have every reason to believe in the success of our new venture.”

Prior to joining QPS, Chen held executive positions at Wyeth Pharmaceuticals and as a senior advisor to the Industrial Technology Research Institute (ITRI) in Taiwan.

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eResearchTechnology Net Income Up 62%

Tuesday, August 5, 2008 11:19 AM

eResearchTechnology (eRT), a provider of centralized ECG and eClinical technology, ePRO and other services to the pharmaceutical, biotechnology, medical device industries, reported second quarter net income jumped 62.5% to 13 cents a share on revenue that increased 43.4% to a record $35.5 million.

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Medpace Hires Executive to Open Bioanalytical Lab in Fall

Tuesday, August 5, 2008 08:00 AM

Cincinnati-based Medpace, a global contract research organization (CRO), has hired Yong-Xi Li as Executive Director of its new Medpace Bioanalytical Laboratories. This new laboratory is projected to open in fall of 2008 and will complement services provided by other Medpace research facilities, such as Medpace Clinical Pharmacology and Medpace Reference Laboratories.

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March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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