Khelan Patel, Director
Innovation—a favorite catchword among entrepreneurs—continues to be the driving force for productivity and profit across industries. Along similar lines, the biopharmaceutical landscape has been advancing rapidly. Conventional small molecule development pathways are no longer the norm, and a focus on gene therapy, rare diseases, and medtech is shifting the “traditional” drug development paradigm.
All this coupled with a backdrop of increased compliance, regulatory scrutiny and the need for data and analytics that streamline the drug development process, reduce risk, and lower cost to meet the needs of payers means a lot of sponsors need to incorporate an effective outsourcing model.
Biopharmaceutical organizations are experiencing a huge gap between the “need” and the “actual” presence of skilled individuals to harness this technological transformation. In an ambitious bid to help companies steer ahead of this predicament, Proclinical Consulting—with director, Khelan Patel and his team—is guiding businesses from small biotechs to large pharma reduce expenses, achieve scalability and increase productivity, ultimately resulting in increased ROI.
Proclinical Consulting leverages its extensive global network to ensure companies have access to the right resources that have the appropriate experience across all areas of drug development.
Independent of its staffing expertise, the firm’s consulting service is carried out by assigning a dedicated team for its clients. “Aiming to move up the value chain, Proclinical Consulting is focused on taking full ownership with associated governance of clients’ projects rather than just providing a talented workforce for clients to manage,” explains Patel. Service offerings range from regulatory/ quality compliance, drug safety, clinical operations to strategic advisory services.
Proclinical group offers a “hybrid” model, working efficiently both as a consulting and a staffing service provider, according to client requirements.
“An early-stage startup lacks headcount and expertise,” Patel explains, “we can support navigating the early development hurdles and provide strategic operational and advisory services to get a molecule into the clinic by dealing with regulators, vendors, and payers on their behalf.
Aiming to move up the value chain, Proclinical Consulting is focused on taking the ownership of the clients’ projects rather than just providing talented workforce
Once a startup reaches a critical mass and if it has met clinical and investment endpoints, we can engage the staffing side of our business to provide permanent headcount and taper of the consulting support on an ‘as needed’ basis."
“We can also perform due diligence and gap analysis activities for VC and private equity to understand the technological hurdles in investing in a particular asset, in both cases a Go/No-Go decision is the key deciding factor in whether to invest in a particular clinical development asset or not. If you are going to fail, fail early and move on to the next candidate,” says Patel.
"For larger business, our consulting services can support a number of key areas including clinical operations support, technical transfer of assets to delivering educational campaigns to KOLs. An area of significant growth potential is our regulatory outsourcing service which offers companies the ability to reduce their regulatory burden during periods of peak activity such as M&As or asset swaps/divestments," Patel says.
Added to that, Proclinical Consulting eliminates long procurement cycles while collaborating with the vendors on behalf of its clients, thereby reducing downtime and delivering high-quality an opportunity to outsource entire departments with the added benefits of an effective project management structure. With the strain of resourcing taken away, the existing workforce can focus their efforts on other areas that contribute to company growth, such as product development and improving processes, while the interim function gets to work independently. “Our combined recruitment and regulatory expertise enable us to design an innovative human capital solution that fulfills the client's individual needs and is tailored to its business objectives, strategy, and future vision,” says Patel.
Currently, serving clientele in five offices across the U.S., including San Francisco, Boston, New York, Chicago, and Philadelphia, Proclinical Consulting has established a worldwide presence with firms in major cities of Europe, the Middle East and North Africa (MENA) region, and Asia. Aiming to expand its ever-growing footprint in the near future, Patel anticipates that Proclinical will attain a broader client base ranging from Pharma and Biotech to Medtech / Medical device as well.
“We will continue to empower businesses around the world to reduce operational costs without compromising on the quality of the outcome in their drug development processes,” concludes Patel.