Israel Vega
Clinical Operations Manager
PRA Health Services
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The Future of Clinical Trials: Sharing

Wed, 09/07/2016 - 12:34

Q: What are your goals as the new Clinical Operations Manager of PRA Health Sciences?

A: We are determined to reinforce our quality and efficiency, which is why our clinical research associates are constantly looking at how we can improve and accomplish our goals with a quicker turnaround time. Business renewal gives us valuable information on customer happiness and we are doing really well. Internally, as a CRO we have several qualitative objectives we want to achieve and are continuously monitoring. PRA Health Sciences differentiates from other big CROs through creating partnerships with customers to conduct specialized clinical studies. It is much more difficult to find and recruit patients for oncological and rare disease clinical trials. New therapies have been developed for oncology in recent years with no precedents, so expertise is needed but is hard to find.

Q: What are the drivers of double-digit growth in the CRO industry despite stagnant pharmaceutical pipelines?

A: Working with CROs can have different pros and cons depending on whether it is a Big Pharma, midsize or small innovative company. Resourcing clinical development activities has several advantages, such as cost efficiency, and we help them to optimize R&D activities through highly qualified professionals taking charge of them. CRO´s decision to hire depends on geographical presence and commercial interests. Most pharmaceutical companies have preferred vendors, achieved by gaining customer satisfaction through high-quality services, efficiency and meeting budgets. We do not only provide services for innovative companies, we also provide services for the development of biosimilars. Biosimilars undergo the same four clinical phases and pivotal studies and they require the same quality procedures as innovative drugs.

Q: What is the difference between the CRO full service model and staffing services?

A: RPS (a unit of PRA) was one of the first CROs to implement the embedded model in Mexico and it became the leader in this. Now it is part of our Strategic Solutions Department. Many people think this is a staffing service but it is more complicated than that because it consists of hiring an individual that is trained, adaptable to the company’s needs and able work with the infrastructure of the company.

Q: What role do IT systems and digital platforms play in clinical research today?

A: PRA Health Sciences invests a lot in technology, which is continuously evolving and has changed the way we monitor clinical trials and the way data is processed. The activities of clinical research associates today are very different from those in 1999 and 2009. We now collect data in real time and share it with the client. This is the future of clinical research. Immediate detection of risks will be possible and corrective actions will therefore be implemented in a shorter time. We used to provide clinical sites with computers so they could access electronic case reports, while now there are prototypes for accessing electronic forms from mobile devices. Remote monitoring also significantly reduces costs since monitors do not need to visit clinical sites as much as before.

Q: How can clinical trials adopt a broader scope to provide more knowledge of drugs during clinical trials?

A: Clinical trials are the standard scientific method to obtain information about a new molecule but full knowledge of the drug can only be obtained when the drug is taken by many patients worldwide. When pharmaceutical companies partner with CROs they gain specialized knowledge and services. CROs have extensive experience in different therapeutic areas, giving us the expertise to identify adverse events and when a study has successfully met its primary and secondary endpoints through a validated, repeatable scientific method.

Q: How do you envision PRA Health in the short term?

A: Improving quality and efficiency will remain at the center of our agenda. Mexico has the necessary capabilities and key elements. We have excellent sites and proper infrastructure and regulations are supportive. Patients are also increasingly willing to participate in clinical trials.