CLINICAL OPERATIONS & OUTSOURCING


Industry Viewpoint: Growing pains


CTA sits down with clinical consultant Rita Nigam, who shines a spotlight on some of the obstacles that working with a small company presents.


I


n this Industry Viewpoint, Clinical Trials Arena (CTA) sat down with Rita Nigam PhD, a clinical consultant. Dr Nigam


assists companies in managing clinical trials, and part of her role is to forecast budgets and timelines. She is also involved in designing clinical trials and implementing protocols, while ensuring studies are run in a cost- ecient and timely manner.


In this interview, Dr Nigam speaks to CTA editor Henry Kerali about some of the challenges she faces when working with a small company moving from Phase I to Phase II.


CTA: Working in a small company, what would you say are some of the biggest issues you face?


Rita Nigam: Working with a small clinical team and supervising the clinical operations team, while overseeing two to three sponsor trials simultaneously can be challenging. What’s more, these trials are all primarily in oncology. Oncology trials are very complex and can require at least one manager per trial. It is a very competitive field and very difficlt to recruit patients. Most trials are conducted at multiple sites to meet study targets and therefore require a lot of management with a relatively small team. Currently, combination immunotherapy trials


are being conducted. As a result, you have to work with partners that may have different ways of governing their trials and therefore you need to accommodate your partners. It is challenging for a small team to ensure there is proper oversight of the trial and at the same time manage partners. Moving forward from


Phase I to Phase II, combination trials will become very complex.


CTA: To what extent is resourcing an issue and how does the company manage trials with limited staff?


RN: Small companies should depend on clinical research organisations (CROs) and other vendors. Departments that are not being developed in-house should be outsourced to a vendor. Furthermore, the sponsor should ensure they have at least one alified person designated to manage the CRO and other vendors. As new people are hired, especially for more senior positions (project management, QA director, HR, CMO), prior to developing new systems and processes, it is important that any new employee talks to the appropriate people in the company to see what is in place and what is working to avoid duplicating pre- existing processes. Part of the growing pain is the time it takes to


get new employees knowledgeable about all aspects of the company, while at the same time keeping existing employees motivated. Therefore, internal promotions should occur within organisations. However, companies should provide appropriate training to existing employees prior to promotions to ensure a smooth transition.


CTA: In your experience, what have you found to be the best practices of working with limited resources?


RN: Over the course of my career, I have seen companies fully outsource their trials and


Outsourcing In Clinical Trials | 23


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