Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.
Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?
Anyone involved with clinical trials knows a continuing and growing problem in the industry is the lack of qualified clinical research staff. A new report from BioPharm Insight (BPI) acknowledges this trend, noting the staff shortage is a “growing plague to the CRO industry which will need to be addressed in order to ease liabilities.”
When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.
Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.
Oncology is the number one focus of global drug development, accounting for $65 billion in sales worldwide in 2013 and projected to grow 50 percent in the next five years.1 New treatments, new diagnostics and new medical protocols are beginning to unravel some of the scientific basis and pathways of this disease, with measurable impacts on disease progression and quality of life of survivors.
The extraordinary advances in cardiovascular medicine over the past decades have extended and improved countless lives. Drugs for heart-related disease make up one of the biggest selling areas, with hypertension medications alone expected to reach over $24 billion in global sales in 2015. Real successes in reducing the death rate from myocardial infarction and controlling blood pressure and cholesterol are some of the true successes of modern medicine.
Medidata is committed to enhancing and streamlining clinical trials from start to finish—beginning with the trial concept and protocol design to conclusion with actionable data.
WuXi PharmaTech, a leading contract research organization with operations in China and the United States, and PRA, a leading global clinical contract research organization, recently announced that they have signed a joint venture agreement to offer a broad platform of Phase I-IV clinical trial services in China, Hong Kong and Macau.