With brand new INDs, early phase development presents both excitement and challenges
By Kathryn E. Vinson, MS, CCRC
Early stage development of new drugs and devices is both thrilling and can be a little bit nerve racking. Like many of us in clinical research, my career began at the phase I clinic for a large, global CRO. What an exciting time that was in life – fresh out of college, working on INDs that were fresh out of the lab. In my world, it didn’t get much better. Despite that excitement of youth and novel discovery, early stage development of new drugs and devices present their own unique set of challenges. We here at DZS Clinical Services would like to discuss some of those, as well as how we are strategically positioned to address those needs.
The Personal Touch
While many phase I trials are conducted in large, sterile, dorm like facilities, we at DZS understand that settings such as those aren’t always the answer. As a CRO, it is imperative for us to realize that certain populations involved in early stage development such as geriatrics and renal impaired not only desire but require a softer touch than what is often seen in the typical phase I facility. By drawing on our global network of experienced research sites, we can help our sponsors find the perfect setting for their specific trial needs.
Phase I and early phase II studies can be tricky to recruit. There aren’t a lot of people willing to not only give up the time required for inpatient stays, but also accepting the risk of assisting with the development of a brand-new IND. This difficulty is only compounded with trials that need specific populations, such as renal impaired or senior citizens, for example. This is where DZS can shine its brightest. By utilizing our world-wide network of proven partner sites, sponsors can rest assured that their trials in early phase development will be completed with the perfect populations.
Despite the excitement of working on a new pharmaceutical or device, we all recognize that there are risks inherent in the business. While protocols are developed with gradual step ups in dosing and strength for this very reason, researchers can never let their guard down when it comes to safety. To that end, sponsors can rest assured that DZS Clinical Services offers industry leading safety monitoring via the Insight Platform and its customizable Risk Identification Dashboard. When Insight is paired with DZS’s 24/7/365 medical call center staffed by multilingual industry professionals, safety monitoring is taken to a new level of excellence.
Whether you are a sponsor looking for a unique early stage development experience, or a site that is looking to expand its research capabilities, we encourage you to contact one of DZS Clinical Services’ experienced project management teams. Let us show you how we can be Your Direct Line to Improved Clinical Performance.