Theorem Clinical Research

Articles Published in 2009

CenterWatch Monthly December 2009

Wednesday, December 2, 2009 07:32 AM

Maine Revises Clinical Trial Transparency Rule

The revised regulations, which went into effect Nov. 2, are an attempt to clarify the Maine’s requirements for clinical trial registration and results reporting and to make them more compatible with federal reporting requirements under the FDA Amendments Act of 2007, which called for a federal system that expands public access to data from clinical trials.

FDA, OHRP Guidance on Unanticipated Problems and Serious Adverse Events

FDA and HHS regulations require that unanticipated problems encountered in clinical trials be reported. The FDA regulations require investigators to report unexpected, serious adverse events to the sponsor and the sponsor, in turn, shall report these events to the FDA in an expedited manner.

Debate Intensifies Over Future Shape of Safety Reporting

Europe’s system of safety reporting continues to be plagued by a host of inconsistencies, and no stakeholders appear happy with the current mechanisms for handling suspected unexpected serious adverse reactions (SUSARs).

Eye On: Lymphoma

Lymphoma, a form of blood cancer in which white blood cells known as lymphocytes proliferate more rapidly or have a longer than normal life span, may arise in the lymph nodes, spleen or other organs, bone marrow or  blood.

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Quest Diagnostics

i3, Acurian in Patient Recruitment Deal

Tuesday, December 1, 2009 08:01 AM

Pharmaceutical services company i3 has entered into an agreement with Acurian, a provider of patient recruitment and retention solutions, to provide study sponsors with a more robust solution to recruit investigators for clinical trials. 

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Progenitor Launches Resourcing Solutions Division, Gains Traction in Vaccines

Monday, November 30, 2009 11:02 AM

Emerging markets contract research organization (CRO) Progenitor International Research recently launched a Resourcing Solutions Division. 

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Perceptive Informatics Expands Medical Imaging

Friday, November 27, 2009 09:08 AM

Perceptive Informatics, an eClinical solutions provider and a subsidiary of Parexel, a global CRO, has expanded its medical imaging capabilities with advanced nuclear imaging functionality for cardiology clinical trials.

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University of Rochester Medical Center Creates Cardiac Safety Center

Wednesday, November 25, 2009 07:34 AM

The University of Rochester Medical Center announced the creation of a new center that will assist researchers studying the electrical activity of the heart with the goal of improving drug safety, understanding cardiac arrhythmias and developing new electrocardiograph technologies.

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PPD in Compound Partnering Deal with Janssen Pharmaceutica

Tuesday, November 24, 2009 07:38 AM

PPD, a global CRO, has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin, skin structure and respiratory infections.

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Clinipace Acquires Worldwide Clinical Research, Changes Name

Monday, November 23, 2009 07:28 AM

Morrisville, N.C.-based Clinipace, a technology- focused contract research organization (CRO), acquired Worldwide Clinical Research, a Midwest-based CRO as part of its global expansion.  With the acquisition, Clinipace has changed its name to Clinipace Worldwide. 

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i3 Pharma Resourcing Expands in Europe

Friday, November 20, 2009 09:07 AM

i3 Pharma Resourcing launched resourcing services in Switzerland and Belgium.

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PPD Continues China Expansion with Deal to Acquire Drug Discovery Company BioDuro

Thursday, November 19, 2009 03:35 PM

Less than a month after announcing its acquisition of China-based contract research organization (CRO) Excel PharmaStudies and plans to dominate the Asia-Pacific region,PPD, the Wilmington, N.C.-based global CRO has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company. The acquisition of the 660-employee company will expand PPD's drug development capabilities in China.  

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Whistleblower Suit Filed Against Carle Foundation Hospital, Clinic Over Patient Protection

Thursday, November 19, 2009 08:28 AM

Charging that the Carle Foundation Hospital and Carle Clinic failed to protect cancer patients in their clinical trials, Suzanne Stratton, Ph.D, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., filed a whistleblower lawsuit in federal court against the hospital’s chief executive officer, the Carle Clinic Association, Kendrith Rowland, M.D., a lead physician at the Carle Clinic, and Bruce Wellman, M.D., the Carle Clinic CEO. 

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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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