Jesse Kooker, SVP-Global Biometrics
As drug developers face escalating pressure from generic drug firms, patent expirations, and increased scrutiny from the FDA, efficiency is more important than ever–with focus on effectiveness of drugs. Of late, the biopharmaceutical space has become reliant on Contract Research Organizations (CRO) and other clinical services specialists to provide research services. In such a situation, one CRO that is revolutionizing the industry is PRA, through its expert team, innovation, and operational transparency.
North Carolina based PRA Health Sciences delivers a spectrum of full-service and Strategic/Embedded clinical trial solutions—meeting the demands of the contemporary marketplace. The company provides services on a contract basis to the pharmaceutical and biotechnology industries. The services of the company include filing of Investigational New Drug and similar regulatory applications, preparation and submission of New Drug Applications, management and implementation of Phase I through IV clinical trials, and global post‐marketing surveillance.
PRA has established itself as a key player through its specialized expertise and success in a variety of segments—from drugs to niche treatments and therapies. Technological advances, and a forward-thinking approach to clinical research innovation play a big role in separating the company from the rest in the space.“In helping sponsors decide on what platforms are feasible for them, we are adopting the latest technological trends in the market catering to clinical data management,” says Jesse Kooker,Senior Vice President, Global Biometrics at PRA Health Sciences.The company’s level of constant technological integration into the clinical development process is a real advantage in both productivity and in delivering reliable results in an ever-advancing industry.
When people talk about innovation they’re often focused on technology and that is huge part of our business
“We are extremely effective and efficient in our delivery process and we have incorporated elements of technology from beginning to end in the ways we identify patients, as well as scrub social media sites and the analytical data that we use to identify patients,” mentions Kooker. Through its biometric services, PRA has implemented a number of technologies that can manage the data more efficiently—encouraging the standardization of data. Kooker adds, “When people talk about innovation they are often focused on technology and that is huge part of our business.”
PRA provides its clients with one of the most flexible clinical development service offerings, which includes both traditional, project-based Phase I through Phase IV services as well as embedded and functional outsourcing services. The company has invested in medical informatics and clinical technologies designed to enhance efficiencies, improve study predictability, and provide better transparency to clients throughout their clinical development processes.“We have invested in solutions that will take raw data from the EDC systems and transform it into SDTM in a very short period of time,” explains Kooker.
Since 2000, PRA has performed more than 3,100 clinical trials worldwide and has worked on more than 100 marketed drugs across several therapeutic areas. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration’s (FDA) approval of important drugs currently in the market.“As a CRO, being on the services side of the industry, one of the biggest challenges is getting our sponsor organizations to look at us as colleagues rather than resources,” informs Kooker.“We have proven capabilities to provide complex services which allow us to create customized solutions for our clients.”