Outsourcing in clinical research has helped accelerate digital transformation in the field, optimize processes, and advance the buzzwords, decentralized clinical trial methods.
Aspirations and projections
Through outsourcing clinical support for clinical research organizations, the goal of being able to advance cures to the market as quickly and as safely as possible becomes all the more attainable. There is the goal as well of increasing the diversity and access to research through reaching more people and more geographical locations. As there are already shifts to decentralization of research and more holistic approaches, the future of research, specifically that which is geared to advance human health, is encouraging. All these aspirations, though, wouldn’t become possible if we don’t make sure that the basic requirements are covered and the observed issues cleared.
Issues and requirements
Just like in all other areas and industries, data handling and security also figure among the top concerns in clinical research, especially in its adoption of digital transformation. Data integrity, i.e., data accuracy, reliability, and consistency, is also an issue, one that always comes up in discussions as to how to design the study.
Another issue, which has kept appearing in recent articles on outsourcing clinical research support, is safety. Now－perhaps including all good intentions－research companies, organizations, and sponsors, would prefer a one-stop-shop when outsourcing clinical research support.
Natalia Vicek, a pharmacovigilance and quality assurance expert, notes in a DDW article that despite “offering full-service outsourcing, safety is often an add-on.” One way to avoid this, she says, is to prioritize effective communication. It is important that all requirements and arrangements are communicated prior to each exchange of information (e.g. with the sponsor, the vendor, the patient or participant). Another way is to avoid applying a one-size-fits-all approach as there are, of course, no studies that are identical.
For international clinical trials, it is important to have full knowledge of compliance with local business and regulatory environments. For this, it becomes convenient to be able to outsource clinical research to a CRO with local expertise. Expertise with the local regulatory environment, though, doesn’t automatically guarantee adherence to ethical standards. This could mean that what they call their “local expertise” is just about knowing whose desks should money be sent to do the talking. Be sure to have a compliance checklist to easily identify red flags and prevent compliance risks.
Frameworks and approaches
Rob Wright, Chief Editor of Life Science Leader magazine, once said in a May 2012 article on selecting a CRO, “what was once referred to as outsourcing is now called strategic partnering.” Basically, it is. “By developing strategic partnerships with CROs, large and midsize companies have been able to capitalize on a reallocation of financial resources, moving from the fixed-cost internal R&D model to one which is more variable and external to the organization.” Meanwhile, for small bio/pharma companies, strategic partnering is always an essential component of their business model.
Regardless of the size of the company or organization, the partnership could be said to be strategic if they look closely into the details of all provided and available information prior to selection. Among the things that need looking into are oversight and policy regulatory frameworks, as well as guidelines regarding research roles and responsibilities. It is also worth considering whether there is an alignment of vision. One would prefer, for example, a holistic approach to well-being, while the other is used to limiting their findings to immediate therapeutic effects.
Outsourcing for Clinical Research
The selection process, therefore, should take into consideration the needs of the research in relation to the desired end result, as well as each research phase or milestone as necessary. The research could, for example, require a drug-centered approach, an approach focused on process improvement and efficiency, or a participant-centric approach. CROs also have different core specializations and expertise, as well as different levels of experience with those outside their declared or proven core specializations and expertise. It would be wise, then, to consider those in deciding whether they could be the one-stop-shop CRO you’re looking for or should you need to outsource different CROs for the different research stages.
In other words, you’re outsourcing strategy should be systematic. Through looking well into the details, you should be able to come up with a systematic analysis of which processes and trials you need to outsource, as well as the right partner in needed geographical locations.
Insofar as outsourcing is concerned, you may find more helpful tips in a related article, 8 Tips in Finding the Right Outsourcing Company.
If you need assistance in selecting the right strategic partnership for you or in outsourcing clinical support, we at StratAccess could help you with it.
StratAccess Inc., established in 2012, commits itself to find its clients the BPO in the Philippines for successful business solutions. The company focuses on transforming the landscape of call center partnerships. This is important in order to meet the requirements of today’s small and medium-sized enterprises (SMEs). StratAccess consultants stand ready to help clients take a hard look at their business objectives, organization infrastructure, and operational practices.
We at StratAccess strive to build long-term relationships that extend beyond the typical vendor-client transactions. Our primary focus is to successfully promote and serve each client’s products or services as though they are our own. Combined with the skill and knowledge of the Philippine outsourcing industry, our company has positioned itself as a leader in delivering its clients access to qualified quality and cost-effective BPO referrals.