CLINICAL OPERATIONS & OUTSOURCING


“Try and cultivate a team with diverse backgrounds. In clinical trials issues will always arise and, as a company, if you can draw on various insights from people who have experience in different areas that will enable you to resolve any developing problems in a timely manner”


the sponsor does not identify someone internally to manage the CRO. Firstly, it is essential that sponsors choose a sponsor representative with appropriate experience to provide CRO oversight to ensure the company achieves their goals. Secondly, try and cultivate a team with


diverse backgrounds. In clinical trials issues will always arise and, as a company, if you can draw on various insights from people who have experience in different areas that will enable you to resolve any developing problems in a timely manner. Another reason why it is important to assign one manager per trial is to provide excellent customer service. It is important to have a 24 to 48-hour response turnaround to any questions or issues that arise at clinical sites. That will allow you to maintain the clinical site’s interest in your trial and study timelines.


CTA: Could you provide a real-life example of dealing with an underperforming vendor?


RN: With one company, we decided to conduct certain aspects of a clinical trial in-house for a small, Phase Ib oncology trial at two clinical sites. ore specifically, the sponsor condcted clinical trial management and monitoring in-house, and outsourced data management to a small, local group. The data management group had limited experience in oncology and resources. As a result, study timelines were extended to resolve all data queries at the clinical sites prior to database lock. The sponsor also realised that it was a lot of wor  maintaining the trial master file T,


24 | Outsourcing In Clinical Trials


monitoring and developing standard operating procedures (SOPs) – to conduct clinical trials in-house with limited staff. At the time, the company had budgetary constraints, but no matter how small or the phase of the trial, you require all types of skillsets in the various departments (medical, regulatory, clinical trial management, project management, data management, etc) to successfully conduct a clinical trial. So, it’s best for small companies to outsource to full-service CROs. In the long run, you will save time and money.


CTA: Lastly, what advice would you give to another small company dealing with similar resourcing issues while conducting complex studies?


RN: It is critical to have the right people in place who are knowledgeable in managing clinical trials prior to hiring a CRO. You need to develop your clinical resourcing plan, based on the clinical phase of your company. For example, when a company progresses


from Phase I to Phase II, quality assurance (QA) is very important, especially for manufacturing and product development. Moving forward into Phase II, and potentially Phase III, regulatory becomes a priority. Based on the clinical phase of your company, you need to hire the appropriate resources well in advance of proceeding to the next phase.


To follow-up with Rita Nigam with any questions or concerns, she can be reached at ritanigam20@gmail.com.


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