Insights On Partnering

  1. What To Do About India

    When you read some of the news regarding pharma manufacturing in India, the headlines are not good. Much of the narrative is negative and seems to be spiraling downward. Unfortunately, in today’s world the perception is often the reality, and the reality has us shaking our heads in wonder.

    FDA commissioner Margaret Hamburg has come out with a clear statement on the situation: Indian companies have to take more responsibility for quality control. Oh, and by the way, the FDA is also ramping up cGMP audits in India. When the FDA makes these kinds of statements, the industry listens.

  2. Healthcare Company Expects Online Collaboration To Save Millions Of Euros

    Sanofi is a multinational pharmaceutical company engaged in the research and development, manufacturing, and marketing of prescription drugs, vaccines, and over-the-counter healthcare products.

  3. Considerations When Selecting A CRO For Phase I Clinical Studies

    Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

  4. Recruiting Patients With Impaired Renal Function Case Study

    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.

  5. Cognizant’s Clinical Transformation: More Than A Solution, It’s A New Way To Work

    The pharmaceuticals industry is at a turning point. Many prescription drugs are leaving patent protection; getting new patents takes longer than ever before and can cost tens or hundreds of millions of dollars.

  6. Phase II Alzheimer's Case Study

    A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.

  7. Eight Best Practices For Compliant Essential Site Regulatory Documents

    In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

  8. Moving Towards An Electronic Environment In Clinical Trials

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

  9. The Sunshine Act - It's Finally ‘Official’

    So now that the long wait is over for the final rule, where do you go from here? On February 8th, 2013 the final rule of the Physician Payment Sunshine Provision (PPSP aka "Sunshine Act") was released by The Centers for Medicare and Medicaid Services (CMS). By Kevin Williams

  10. Don’t Take It For Granted

    Investigator grant payments are typically the single greatest expense in a clinical trial budget, often accounting for 40 to 60 per cent of the total budget. By Kevin Williams, CFS Clinical