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Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring

Industry news focusing on the people and organizations who work in the clinical trials profession.

Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring.

Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring

Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry

Crown Bioscience, Inc., a leading global drug discovery and development service company, today announces that it has acquired the shares of Preclinical Oncology Services Limited (PRECOS), a leading pre-clinical research and development service provider with a specific focus on oncology.

Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry

A recent Twitter follower asked in regard to RBM technology, "Is there any experience w/regulators utilizing tool data as a roadmap to ID trouble sites during inspections?"

CRF Health, the leading electronic Clinical Outcome Assessment (eCOA) solutions provider announced several innovative enhancements to their TrialMax eCOA solutions.

Collaboration greatly reduces cost and administrative burden in clinical research.

Accessing and engaging patients is a very difficult task in today’s environment, as there is a bombardment of numerous media vehicles, including digital media, with varying intensities that penetrate patients’ senses, emotions, and thoughts.

Physicians are increasingly advocating a patient-centered approach to practicing medicine, and both regulatory agencies and manufacturers also seem to agree that patient reported outcomes (PROs) are valuable.

Clinical Research Organization Utilizes M-Files ECM for FDA 21 CFR Part 11 Compliance; Integrates M-Files into SharePoint and Dynamics SL

Offices in Osaka and Shinagawa in Tokyo provide strong clinical development hub for customers in world’s second largest pharmaceutical market

KMR Group

On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) as a modification to the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."

On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) which modifies the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."

Quintiles report of health care executives reveals how to improve success in a new competitive landscape

Clinical Research Advantage (CRA), a network of clinical trial sites, has further expanded its geographic and therapeutic reach by acquiring the late phase division of Comprehensive Clinical Development (CCD).

Data Sharing Commitments will Enhance Research and Scientific Knowledge, Advance Patient Care and Improve Public Health

In the febrile atmosphere of Europe's debates on transparency, could there have been a worse moment for the recent allegations in the UK daily newspaper, The Guardian, that the drug industry is secretly pressuring patient associations to advocate restrictions on the release of clinical trial data?

With all of the talk and emphasis on data and using technology and tools to determine better monitoring strategies, the other component becomes operational. What will companies do internally to manage a monitoring shift?

Courtney McBean, president and co-founder of Blueprint Clinical, explained in Part 1 about what made her decide to start up a technology company that specifically addresses risk-based monitoring (RBM).

In the past week, I?ve had two interviews and one webinar all related to some form of safety measuring and diagnosis definition primarily in the CNS area.

A consortium of leading biopharmaceutical companies is moving forward with several projects to make clinical trials more efficient and less costly.