Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.
It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.
Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?
Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?
Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle? Or do you work at a sponsor or CRO where you feel sites are making up study budget numbers or are never happy with any budget proposal?
In this article, I’ll share insights on how sponsors and CROs set up overall study budgets and discuss five secrets to getting your dream budget approved.
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
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.