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Headlines > Clinical Development

Over 1,000 Chinese NDAs rejected due to 'fabricated or incomplete clinical trial data'

28-Sep-2016 - The China Food and Drug Administration (CFDA) has withdrawn 1,184 drug registration applications following a recent yearlong government investigation into clinical trials in the country.

Envigo forms advisory group to guide R&D

28-Sep-2016 - The Science and Technology Advisory Group (STAG) was launched as a vehicle to focus R&D initiatives within Envigo and will run across all its service offerings.

Researchers: unpublished adverse reactions a 'serious problem'

27-Sep-2016 - As the industry works to increase transparency in clinical trial data reporting, researchers have found that data on adverse effects remain largely unpublished.

Parexel to acquire functional service provider ExecuPharm

26-Sep-2016 - Parexel has entered into a definitive agreement to acquire ExecuPharm, a global functional service provider (FSP), in a deal that it said will add scale to meet growing demand.

Worldwide Clinical Trials opens new facility in Poland

26-Sep-2016 - The 315 square meter facility will house more than 30 employees in Warsaw, Poland, where the company contract research organization (CRO) has operated since 2008.

The final rule: trial data to be made public in a 'change of business as usual'

22-Sep-2016 - The Obama administration recently finalized new rules that require researchers to make trial data public as the industry grapples with evolving data standards and looks to uphold its pledge to...

The riskiest drugs to develop? Diabetes treatments, says Tufts report

21-Sep-2016 - While the demand for new diabetes therapies grows, the development of endocrine drugs is riskier than all other drug development, according to a study conducted by the Tufts Center for...

Almac Group announces $5.2m expansion

20-Sep-2016 - In conjunction with its 20th year of business in North America, Almac Group has announced a $5.2m investment at its Durham, North Carolina facilities.

iCardiac collaborating with Japanese SMO to conduct cardiac safety studies

19-Sep-2016 - iCardiac Technologies and SNBL CPC Japan, a Japanese-based Site Management Organization (SMO), will collaborate on cardiac safety studies in the country.

ICON completes ClinicalRM acquisition

19-Sep-2016 - The acquisition, which was announced in June of this year, has been completed, expanding the company’s reach into government sponsored research.

PSI selects goBalto's site ID cloud-based software to speed up trials

15-Sep-2016 - PSI has selected goBalto’s cloud-based Select module management system to help manage a multi-country Phase II clinical trial.

Takeda launches 'first-of-its-kind' global observational study

07-Sep-2016 - The open-source study was launched in order to advance understanding of real-world experience with therapies and clinical outcomes in patients with multiple myeloma.

Brexit revisited: focusing on 'the war on talent'

06-Sep-2016 - More than two months after Britain decided to leave the EU, companies reevaluate the state of business and what comes next, specifically for jobs within the industry.

Researchers question traditional efficacy trial model

06-Sep-2016 - According to a recent study, traditional efficacy trials have limited applicability in everyday clinical practice – an issue which researchers say needs to be amended.

Parexel files with SEC following 'misappropriation of corporate funds'

31-Aug-2016 - Parexel has submitted a SEC filing notifying that its form 10-K will be submitted late due to a “misappropriation of corporate funds.”

Boehringer Ingelheim expands partnership to study rare disease in real-world setting

31-Aug-2016 - Boehringer Ingelheim (BI) and the Duke Clinical Research Institute (DCRI) have expanded their partnership to create the largest patient registry for idiopathic pulmonary fibrosis.

Quintiles, IMS Health announce senior management roles

29-Aug-2016 - Quintiles and IMS Health today announced senior management roles for the future Quintiles IMS corporate leadership team.

CROs, Sponsors nominated for Society for Clinical Research Sites award

29-Aug-2016 - The Society for Clinical Research Sites (SCRS) has announced the finalists for the 2016 SCRS Eagle Award - an award recognizing the clinical research profession.

New Ph I-IV data management system to provide access to clinical trial data in real time

24-Aug-2016 - Biomedical Systems and Foundry Health of Chicago will collaborate to develop the proprietary cloud-based data management system, which will cover all study phases.

Frenova Renal Research expands in Durham, NC

23-Aug-2016 - Frenova Renal Research has opened a new office in Durham, NC and has added several new staff members to its US field offices in in New York, Illinois, North Carolina,...

Bioclinica acquired by private equity firm

22-Aug-2016 - The international private equity firm, Cinven, is set to purchase Bioclinica, marking the company’s latest in a series of purchases as industry consolidation continues.

CRO BioPharma Services acquires BLS assets, expands analytical services

22-Aug-2016 - BioPharma Services has acquired intellectual property and human resource assets from Bioanalytical Laboratory Services (BLS), including a list of validated assays.

How animal models will advance precision medicine

17-Aug-2016 - A year into the program, animal models of human disease could augment NIH’s Precision Medicine Initiative, say researchers.

Adaptive designs: patient value and commercial benefits

17-Aug-2016 - As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.

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Purdue Pharma joins health policy research organization

15-Aug-2016 - Purdue Pharma  has joined the National Pharmaceutical Council  (NPC), a health policy research organization working to advance good evidence and science.

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