Scientist.com
Guiding Researchers through the Compliance Maze

A mature compliance function is indispensable for the success of biopharmaceutical companies that operate in a highly regulated environment. However, often times, the lack of proper know-how to operate these compliance solutions leads to further complications and significantly impacts efficiency and resource allocation within an organization.

Matt McLoughlin, an industry expert with over 20 years of experience working with pharmaceutical companies, both in a scientific and commercial capacity, observes that these complicated compliance processes can hinder the performance of overstretched researchers and organizations. “It can slow down the ability of researchers to deliver projects to identify the next breakthrough medicines,” he adds.

Founded in 2007, Scientist.com was established to accelerate research through the utilization of cutting edge technologies. The company designs tools and platforms that remove roadblocks and make compliance more accessible to the pharmaceutical industry. Be it larger organizations, growing biotechs, or the National Institutes of Health (NIH), Scientist. com works toward providing a customized, effective, and appropriate compliance solutions for each client. “We understand that to enable greater compliance within a regulated service area we need to increase the visibility, traceability, and control an organization has related to the outsourcing of any research,” remarks McLoughlin, Sr. Vice President of Compliance & Category Management, Scientist.com. In the same vein, the company is pioneering a faster, leaner, and more innovation-centric approach to research and striving hard to inform/educate researchers and expand the sourcing options that they have.

At its core, Scientist.com ensures that researchers are constantly working with the most compliant companies in terms of both internal policies and procedures and external regulations. To enable this, the CA-based firm has developed a suite of written assessments that are made available to suppliers to assist a client in determining the correct provider of services. Scientist.com gives researchers tools to ensure that any sourcing project is conducted according to the unique needs of their own organization. This paves the way for enhanced control wherein biopharmaceutical companies can set up their individual marketplace to seek approvals from relevant stakeholders at the appropriate decision point within the entire process.

Through its award-winning COMPLi® functionality, Scientist.com supports the acquisition and sourcing of regulated services, including but not limited to Good Laboratory Practice (GLP) services, Chemistry Manufacturing Control (CMC) projects, biomarkers related services, and acquisition of human biological samples (HBS).

We understand that to enable greater compliance we need to increase the visibility, traceability, and control an organization has related to the outsourcing of any research

For each regulated service area, Scientist.com has worked with the industry to create a standardized written pre-assessment (aka RFI) that each supplier completes to proactively provide critical information to its clients. Each client can then review this information against their own internal standards to make an informed decision on whether to place a project with that specific supplier. To assist both suppliers and clients, Scientist.com provides ongoing support throughout the process to ensure all questions and issues are resolved in a proactive and timely fashion. McLoughlin mentions that the standardized pre assessment prepared by Scientist. com effectively eliminates months of administrative time. In short, by fostering a dynamic model of research, Scientist.com streamlines operations between suppliers and clients. From the legal perspective, Scientist.com has taken a similar approach to develop standardized contracts that has now been accepted by the world’s leading biopharmaceutical companies and over 3800 suppliers to enable their research to be conducted efficiently under appropriate pre-negotiated terms.

Most notably, the company’s role in securing human biological samples for its clients has been significant. Even today, multiple pharma clients rely on Scientist. com to source samples ethically. The company’s strict adherence to regulations allows these firms to stick to their bioethics policies and achieve 100 percent compliance. With more than 400 suppliers and biobanks signed up with Scientist. com, the company has revolutionized how biological samples are sourced in biopharma industry.

As a next venture, the company has further enhanced its COMPLi® functionality to now include VERIF.i®. A first of its kind, VERIF.i is a supplier preassessment program offering standardized physical lab inspections that evaluate the facilities, personnel, and processes supporting the sourcing of regulated services. The program acts as an expansion to the company’s compliance platform and aims to help suppliers and clients save money, time, and resources through proactive assessments and risk mitigation. Scientist.com is also constantly reviewing the commercial due diligence processes it applies to every supplier on the marketplace to ensure that they are fit and proper to be supporting cutting edge research within the pharmaceutical industry. The commercial due diligence it undertakes improves on the due diligence a pharmaceutical company would normally conduct itself as it has built its solution in partnership with its clients. “For every supplier and client we look into various key areas such as financials, data privacy, anti-bribery, and anticorruption to ensure that we are continually keeping them up-to-date with evolving market demands. As a company that puts compliance at the heart of its processes this is a never-ending task,” concludes McLoughlin.