Bioclinica's Safety and Regulatory Solutions division provides optimal drug safety, regulatory affairs and clinical services to CROs and sponsors. Our services are supported by our knowledgeable team members, who have experience in a wide variety of roles within the safety and regulatory sphere of clinical trials.
We wanted to showcase our team members in a series of Q&A blog posts, starting with Engagement Manager Sukrit Singh. Sukrit started working at Synowledge, a global life sciences solutions company providing drug safety, regulatory affairs and relevant IT services, in 2011, moving up through several roles during his time there. After Synowledge was acquired by Bioclinica in September 2015, Sukrit became part of the Bioclinica Safety and Regulatory team. We asked him a few questions about his current role, his past experience and his favorite part about his job. Read his answers below:
Q: What is your role at Bioclinica?
A: As an engagement manager, I handle the client delivery process. The role is part of client relations and is a combination of account management and client delivery. I come from an industrial background of pharmacovigilance and safety and regulatory services, and I'm the single point of contact for all client requirements. Most of our team is in India and I am one of the few people in the Eastern Standard Time zone, so I also serve as a liaison between the teams in India and the United States.
My main objective is to make sure we meet client deliverables per our agreement, and I ensure proper governance and oversight when it comes to all client requirements. I'm actively involved in all project kickoffs and new proposals, I help with responding to new business and I also help in terms of making sure we have good transition from kickoff to the initial phase of a project.
Q: How long have you been working in the clinical trials industry?
A: I did my postgrad in clinical research in pharmacovigilance and regulatory affairs before starting at Synowledge in India. I think my journey has been pretty amazing with my growth in the organization. I started at Synowledge as a drug safety associate, and then I moved into a quality review role. I was also a subject matter expert before transitioning into a team lead and PM manager, handling a team of approximately 20 people. Since 2014, I've been in the engagement manager role in the US. During my six years in the industry, I have been exposed to and have gained hands-on experience with all of the services Bioclinica's Safety and Regulatory division offers.
Q: How has your experience shaped the work you do today?
A: I work onsite with a lot of our clients. My experience in the industry has helped me act as a liaison between the two teams in different time zones. Since I've done a lot of safety work in different roles, I can understand clients' requirements from a technology standpoint and relay the same information to the team back in India. I think this model has paid great dividends in terms of our relationships with customers.
Q: What experience does the Bioclinica Safety and Regulatory team bring to the table?
A: Our team members are experts in working with companies of all sizes on a variety of projects. We have some clients that only use a few of our services as well as pharma companies for which we do the entire case processing. We can specifically cater to each pharma company's requirements. Our team can do a deep dive into clients' requirements and provide sustainable solutions based on our experience and our resources, which is what they're looking for.
Q: What makes Bioclinica different from other companies with safety and regulatory solutions?
A: We have some really amazing customizable drug safety software and proprietary tools that the Safety and Regulatory IT team has developed with the operational team: LitTrace, our literature monitoring and tracking tool; PVTrace, our pharmacovigilance process management tool; and SigTrace, our end-to-end signal management tool. These three monitoring tools have immensely helped our customers optimize their existing processes and have been widely appreciated by our customers. While many competitors do monitoring manually, we've found that our robust, validated solutions have brought a lot of value to our clients.
These are tools that set us apart from our competitors because they were created with our customers' needs in mind. We actually developed them in collaboration with one of our existing customers who had those requirements. Also, our understanding of the whole domain has helped us build the solutions to cater to that customer's requirements. We then had these tools as a solution for other existing customers.
We can also always customize these tools based on what the customer requires. If they need something else, we work with them and we can modify our solutions to fit their needs.
Q: What is your favorite part of your job?
A: We've worked with all types of pharma companies. My favorite part of my job is doing a deep dive into understanding how they work with their existing processes, learning what their shortcomings are and figuring out how we can facilitate and optimize their existing work. We also help them set up their pharmacovigilance systems, provide them with necessary training and help them understand the submissions or other requirements they may have via an open discussion. We have that knowledge as an organization, and it's exciting to exchange that with companies because every company has its own way of setting up a pharmacovigilance unit. Making sure we are catering to the client's requirements and upholding standards is one of my favorite parts because it's pretty challenging and it's been pretty interesting.
Want to learn more about our suite of safety and regulatory solutions? Contact us!