Challenges Faced While Working with CROs

Pharma Tech Outlook: Pharma Tech Magazine

Challenges Faced While Working with CROs

Pharma Tech Outlook | Wednesday, December 29, 2021

Whatever the motive for outsourcing research to CRO partners, firms are making a significant investment by entrusting their therapy to these organizations. Even the tiniest biotech businesses have the ability to influence CRO performance, therefore they must be proactive in preparing project teams and insisting on transparency throughout the project.

Fremont, CA: Many companies are working with or planning to cooperate with a contract research agency. Sponsors outsource for a variety of reasons, including lower costs and shorter IRB cycle times, increased efficiency by collaborating with CROs that appear to have well-honed processes, and a higher chance of regulatory packet approval. Working with CROs is, without a doubt, a great approach to managing a clinical trial. But there are always obstacles to overcome, and they can be costly, infuriating, and dangerous. Fortunately, the majority of CRO-related concerns may be avoided.

Challenges of working with CROs can be:

Losing control of the timeline

Many sponsors claim that their CROs do not evaluate all of the study's risks and realities during scoping. As a result, delays are unavoidable — and as timeframes lengthen, expenses rise. Companies may expect that their CRO would "make up the time elsewhere," but in most circumstances, this is unrealistic. It also usually necessitates additional resources and unanticipated costs.

In CRAs and project teams, general vs. therapeutic knowledge is important

Some CROs work hard to ensure that each project has resources with specific expertise or experience, but not all do. Furthermore, many CROs have obtained much of their experience on the job. Some of the CRAs that organizations interact with may have a broad range of experience but lack therapeutic area specialization. That isn't a problem for some research. However, in more sophisticated investigations, it may delay the start of the trial. The CRO team may find it difficult to ingest a company's contents. Deliverables may be of poorer quality for businesses. Worse, it may make more mistakes throughout the study as a result of a lack of preparation or critical thinking skills.

Lack of transparency

When sponsors outsource research to CROs, they're essentially handing up control of many of the day-to-day activities. They are, however, still in charge of the outcome. Sponsors may become anxious if there isn't clear and honest communication at every step. Furthermore, CROs that use information systems but do not provide the sponsor access, cause trust concerns. Worse, when a system is used but not updated on a regular basis, trust is eroded.

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