Complex clinical trials require impeccable frequent reviews of data and skilled clinical oversight. The CRA needs to demonstrate a great level of proactiveness, problem solving and decision-making abilities.

CRAs with less experience struggle to understand the needs of the study and often feel overwhelmed or incapable of fulfilling such high study demands and sponsor expectations. This leads to improper oversight of trial activities, delayed awareness of issues and subsequently leads to daunting effect on integrity and accuracy of trial data.

CRAs with less experience struggle to understand the needs of the study and often feel overwhelmed or incapable of fulfilling such high study demands and sponsor expectations. This leads to improper oversight of trial activities, delayed awareness of issues and subsequently leads to daunting effect on integrity and accuracy of trial data.

The CRA is a single interface between two most important stakeholders in a clinical trial (Sponsor and Investigator). Therefore, the CRA must have a balanced approach to ensure proper and ethical conduct at the site while not overlooking site’s willingness and motivation to contribute to the trial. The CRA needs to act as an expert sponsor representative rather than just a billable resource on the study.

Therefore, at CRA4U, we hire highly experienced and passionate CRAs. We have hired CRAs who have got very substantial academic credentials. They have worked on global complex clinical trials, and they thoroughly understand the scientific aspects of the trial. They work collaboratively with cross-functional teams, participates proactively in discussions and risk assessments and brings value to the trial rather than working in isolation.

CRA4U understands what YOU, as a sponsor, expect from the sites

Our CRAs have also monitored in public health studies which are conducted in isolated and remotest regions globally and requires our CRAs to travel and remained stationed to those places for a long time. Our passionate team of CRAs have travelled to several African and under-developed APAC countries to provide monitoring services.

Monitoring in public health studies requires a flexible and nimble approach. We have developed a dedicated working model to cater to clinical monitoring in public health studies.

We have worked with inexperienced sites with scarce resources and research-naïve project delivery teams where we educated the sites to ensure that the trial activities are conducted as per regulatory requirements. Our agile delivery model public health studies works well for projects that are operating in a resource and cost-constraint environment.

As per ICH GCP, the sponsor is responsible for ensuring quality and integrity of the trial even when some of all components of clinical trials are managed by a vendor. The regulatory agencies are increasingly becoming interested in understanding how such an oversight is managed by the sponsor.

We have developed a “CRA oversight working model” as per which performance of all our CRAs is closely monitored and senior management team is directly involved in effective conduct of the trial monitoring activities.

Our expert team has also conducted more than 200 CRA oversight visits for other organization to independently assess and certify appropriate CRA oversight on the study. Such detailed experience has helped us implement a robust mechanism within CRA4U to validate the best delivery from our CRAs.