With all of the focus on patient centricity and patient-centered clinical trials, it’s easy for the focus on investigative sites to be lost. Prior to the patient-centricity movement, at least for a time, site engagement was the concept du jour in the industry with conferences, articles, and surveys exploring and expounding on the importance of enhancing site relationships. And while some still believe that “patient centricity starts and ends with the investigative site,”1 it seems that the needs of the sites only get cursory attention these days. Not to detract from the importance of patient centricity, but without engaged and efficiently operating sites, many of the patient-centric initiatives will fall short of expectations. As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.
Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem.
Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.
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According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such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.
Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.
With decades of experience in clinical trial design, inVentiv Health offers a full range of clinical trial services including bioanalysis, biostatistics, data management, feasibility studies, global safety and pharmacovigilance, medical writing, project management, protocol and case report form design, quality assurance, regulatory affairs, risk management, site management, strategic planning, and study monitoring.
As a Clinical Outsourcing provider, RDP Clinical offers a scalable resourcing model that provides a comprehensive Clinical Site Management and Monitoring function across multiple projects, therapeutic areas or entire clinical programs.
Whether it is comparative effectiveness, outcomes or increasing market penetration, our Late Phase and Outcomes Research Group capitalizes on the expertise of our dedicated Phase IIIb/IV project operations group coupled with our extensive experience in scientific services and outcomes research.
ICON’s Lifecycle Sciences group offers the full range of services to assist clients with activities throughout the product lifecycle.
