SESSION REVIEWS
Development of Oncology Products in the EU and US.
Session poses the question can we do better? More...
Is It Truly Informed Consent?
Speakers at DIA's 45th Annual Meeting discuss indepth the stumbling blocks of informed consent and potential solutions that may clear the way. More...
FDA Responds to a Growing Global Market.
How FDA is responding to the demands of a global world, where agency-regulated products are in the trillions. More...
EXHIBIT FLOOR BUZZ
Microsoft announced the winners of its 2009 Pharmaceutical and Life Science Innovation Awards, which recognize companies within industry for their innovative use of Microsoft-based solutions. This year, Harvard Clinical Research Institute (HCRI) walked away with the award for "Clinical Development." The academic research organization was honored for its successful adoption of TranSenda's Office-Smart Clinical Trial Manager to provide a higher level of efficiency. "We're proud of this award," J. Spencer Goldsmith, HCRI's president, told Applied Clinical Trials. "As an academic research organization we rely upon many different systems. We're pleased with how we can integrate Microsoft."
PHT, Almac, and Medidata Solutions co-hosted an exhibit floor event whereby attendees would visit each booth to track a patient from randomization in Almac's IXRS integrated IVRS and Web response system, to electronic patient diary entries in the PHT LogPad system, and ending with CRF data entries in Medidata Rave, where they could view all previously entered data in one system.
Off the Exhibit Floor Buzz
DIA brought together FDA and biotech sponsors for a second year to discuss issues critical to biotech in regard to regulatory. Following are some quotes:
Paul Eisenberg, MD, MPH, senior VP regulatory affairs and safety at Amgen, observed that science moves faster than regulatory changes in clinical trials. "It is critical to bank samples to maintain for future analysis so you can go back and ask questions when you have new science."
Steven Kozlowski, MD, director of biotech products at CDER, FDA, advised biotech sponsors: "The best way to deal with agency is to tell a story; a narrative on how you see things. Provide a good rationale and tell your story well and document it."
Joseph Johnson, VP, regulatory affairs and quality for Isis Pharmaceuticals, said: "It is incumbent on us to be responsive and proactive to FDA...requires a more proactive interface."
SPEAKER INTERVIEWS
Change in the Global Regulatory Affairs Function
 | Kenneth A. Getz, senior research fellow for Tufts CSDD and Chairman of CISCRP, speaks to Managing Editor Kerri Nelen about the evolving regulatory affairs function within the biopharmaceutical industry. More... |
Site Relationship Management: Dialogue Ramps Up
| Beth Harper, MBA, president, Clinical Performance Partners, offers Site Relationship Management initiative insights from the past year. More... |
Rewards for Subjects, an Ethical Dilemma?
| Felix Gyi, PharmD, MBA, CEO of Chesapeake Research Review discusses ethical rewards for patients in clinical studies and how the relationships between pharma and health care professionals affects subject recruitment and retention. More... |
Biotech Executive Roundtable Fosters Discussion
| Marie Dray, president, DIA Board of Directors, discusses the importance of networking and discussion for the biotech DIA member, as well as biotech interesting topics for the clinical trials professional to explore. More... |
NEWS
Health Decisions Launches New Website to Get People Talking About Adaptive Clinical Trials
Phase Forward Announces a Growing List of Customers for its Empirica Trace
Clinical Trial Operations Take to the Field with CTMS from Winchester Business Systems
Clinipace Extends Partnership with ImproveCareNow
SAFE-Biopharma Changes Fees to Help Clinical Investigators, CROs, Others
Market Research Firm Cites Oracle as Top Software Vendor for the Life Sciences Industry
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