Clinical Trials On Bio

1. Expediting Companion Diagnostic Development Through Collaboration 1/2/2014

   August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

2. Applications For Circulating Tumor Cells To Support Clinical Trials In Asia 10/11/2013

   Advances in our understanding of cancer have accelerated the development of new diagnostics over the past decade. Now, when assessing the efficacy of an experimental drug, clinical trial teams can supplement traditional markers from tissue biopsies with assessments on circulating tumor cells (CTC). The rollout of such tests has, to date, largely been limited to Western markets, but this is changing. By Ken Pennline, Ph.D., Vice President and, Global Head, Cytometry Services, LabCorp Clinical Trials

3. Compliance Cloud - A Life Science Platform 7/12/2013

   The NextDocs Compliance Cloud is a state-of-the-art delivery platform for the NextDocs compliance suite and was built from the ground up for the Life Sciences industry.

4. Evolving A Global Document And Knowledge Management Solution At Arizona Chemical 7/12/2013

   Like any process manufacturing organization, Arizona Chemical had amassed a huge number of documents detailing the processes and procedures central to its operations.

5. NAPP Dumps Old System To overhaul Its SOP Management With NextDocs 7/12/2013

   NAPP Pharmaceutical Group, a leader in the field of pain control, had been using the same Documentum/QUMAS-based document management system since 2004 to manage and maintain its SOPs. Unfortunately, by 2010 the system was showing its age.

6. Sanofi Pasteur MSD Inoculates Itself Against Document Management Inefficiency 7/12/2013

   Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today.

7. Validation Approaches, Tools, And Services 7/12/2013

   Validation is a documented process that demonstrates that a system was developed, implemented, operated, and maintained in a controlled manner.

8. 21 CFR Part 11 Challenges And Solutions 7/12/2013

   Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11).

9. Healthcare Company Expects Online Collaboration To Save Millions Of Euros 7/2/2013

   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.

10. Clinical Training And Assessment Group Improves Data Validity; Yields Only Positive Pivotal Study 6/21/2013

    A sponsor was conducting two parallel panic disorder studies to assess the efficacy of an antidepressant across 95 sites throughout Europe.