Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Despite the focus on innovation at conferences, TED talks, and other forums in the last few years, as an industry we are still very slow to innovate and even slower to adopt new technologies, best practices, and methods. This intense fear of adoption in our industry is what I affectionately call “adoptaphobia.” Adoptaphobia refers to our industry’s fear of and reluctance to adopting new initiatives, best practices, and technologies to create efficiencies and reduce redundancies. We love to talk about issues and deliberate and discuss new methods, but we are extremely slow to commit and adopt the recommendations and methods that we agree would make everyone’s lives easier and streamline the process.
Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.
If you are involved with clinical trials, you are aware of the shortage of qualified CRAs. Numerous reports have noted the continuous increase in turnover and salaries for these clinical professionals. We know the problem exists, but is there anything we can do about it?
Six things that high-performing clinical research sites do that make sponsors return to them again and again.
Recording, managing, reviewing and approving required Trip Checklists and Monitoring Action Items (MAIs) can be challenging. The Monitoring Trip Checklists tool allows monitors and clinical managers to easily do all of this in a centralized location within iMedNet.
Manually reviewing and approving site payments is time consuming, costly and prone to errors. The iMedNet Payment Manager quickly automates this process so study administrators can easily apply site specific study budgets, view and approve eligible payments, and access a complete transaction history.
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.
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.
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.
BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.
CFS Clinical (CFS), a specialty provider focused on the business and financial management activities for clinical trials, recently announced the launch of its upgraded technology platform and new tax consulting services.
Stiris Research has entered into a strategic partnership with Statistics & Data Corporation (SDC) to offer seamless implementation of full-service Clinical + Biostatistics and Data Management/EDC solutions.
Accelovance, an award-winning clinical services company, announced recently the addition of Stephan A. Bart Sr., MD as Chief Medical Officer for the organization.
CRA Holdings, LLC announced recently that it has acquired Radiant Research, Inc. CRA Holdings is the company that also owns Clinical Research Advantage (CRA), another major player in the SMO market.
CFS Clinical (CFS), a specialty provider focused on the business and financial management activities for clinical trials, has been selected by the Philadelphia Business Journal as one of the region’s Best Places to Work.
Darlene Panzitta, President and Founder of DSP Clinical, is among this year's PharmaVOICE 100 List of the most influential people in lifes sciences industries.
CFS Clinical (CFS), a specialty provider focused on the business and financial management activities for clinical trials, is pleased to announce the launch of our revolutionary technology platform — CFS InSite, which supports all of the company’s services.
Clinical Financial Services (CFS), a specialty provider focused on the business and financial management activities for clinical trials, announces its new name and brand image.