-
Categories
-
Recent Posts
-
Recent Comments
- Joseph Francis on Europe’s Top Regulator Shows His Teeth
- Joseph Francis on Pfizer’s Virtual Trial Recruitment
- Nimer Yusef on Can “Clinical Data Integration on the Cloud” be a Reality?
Tags
CBI China conference CRO/Sponsor CROs data DIA drug development eClinical EDC EMA EU Europe European Medicines Agency facebook FDA IIR India IT JOhn Dalli Kayda Norman Ken Getz Lisa Henderson London oncology Oracle Partnerships in Clinical Trials patient/subject recruitment patients Peter O'Donnell Pfizer Pharmaceutical Executive Pharmaceutical Technology Philip Ward PRO R&D Regulatory REMS Sites social media subject recruitment subjects Tim Denman UK Wayne KubickJoin ACT for discussions, news, and more on
Author Archives: Marissa Shapiro
Writing Proposals: The Competing Goals of CROs and Sponsors
A recent CBI conference, Contracting for CROs, brought to the surface lingering issues that exist in the CRO–Sponsor relationship—particularly those pertaining to the proposal process.
While sponsors want to view proposals in a standardized manner and CROs want to seize the opportunity to break the mold, there simply is not enough room for both.
Ravin Warnakulasuriya, Vice [...]
Dos and Don’ts of DMCs
When responsible for safety monitoring in a clinical trial, there are likely to be challenges faced, ethical issues, and grey areas. Whether you yourself are a part of a data monitoring committee (DMC) or may one day do business with one, there are several key things to pay attention to.
Potential Challenges
Offering their advice on the [...]
Posted in CRO/Sponsor Leave a comment
Keeping your Data Clean with DMCs
Data, data, data—probably one of the top five headaches of the clinical research professional. There is an overabundance of data spewing out from every angle of the clinical research process. But while minimizing the amount of it would offer relief, the risk of not having enough could surely bite back.
With new and preexisting methods for [...]
A New Years Resolution for Your Business
As 2010 approaches, and even blindsides some of us, companies and organizations are putting together new budgets, agendas, and strategies. With the many obstacles seen in 2009—economic plunge, heightened regulations, looming health care reform—it’s no doubt the majority will be preparing for change.
As usual, regulatory agencies in their ever-evolving ways will certainly have to address [...]
Need a Job?
Whether you’ve lost your job, sense downsizing in your company’s future or just want to see what kind of jobs are floating around out there, you should check out these career sites. I scanned through about 100 sites that were included on Weddle’s 2009 poll for job seekers to find the most relevant ones for [...]
Top 5 Business Model-Making Mistakes
As times change it is inevitable that your business model will have to as well. In my last blog, “Making Over Your Business Model When Job Cuts Are Not Enough,” I discussed the current trends in business model making for some of the larger pharma companies and the outlook for these and other potential models [...]
Making Over Your Business Model, When Job Cuts Are Not Enough
There are four typical reasons a company would have to revisit its business model, according to Surya Chitra, principal consultant for Savio Group Inc., and Savio Technologies LLC:
1. Economic reasons (current global economic recession)
2. Political influences (e.g., the health care reform with drastic implications for pharmaceutical industry)
3. Regulatory restrictions/vigilance (extra scrutiny about the way approval [...]
Posted in CRO/Sponsor Leave a comment
Sponsors to See More Costs Ahead
It is no secret that the newest leadership of the FDA has been pushing to crack down on underlying issues that had typically put the agency in a bad light and sparked criticism from the public. Most recently, the “Safe Use” program has gained discussion as a means to fixing the dangerous and unavoidable medication [...]
Is Freelance for You?
“The escalation of layoffs in clinical research, and the resulting job insecurities, has had a significant effect on the growing numbers of clinical professionals who choose self-employment.” Though Lisa Provan made this statement in an Applied Clinical Trials article published back in 2003, I think it’s safe to say we are experiencing similar trends in [...]
Flat or Fallen Growth for Research