With the advancement in technology, research has gained a multiplied importance and thus, most of the pharmaceutical companies are now rushing behind for outsourcing their research to various CROs. In other words, one cay say that a Contract Research Organization has become an undeniable part of the pharmaceutical industry today.
Both the large and small pharmaceutical companies partnering with the CROs for accomplishing their clinical studies expect the overall outsourcing levels to advance further beyond the present scenario. Most of the CRO’s today are engaged in providing clinical study assistance and support both for drugs and medical devices. Furthermore, they assist their pharmaceutical clients with their expertise as well as means of moving a new drug entity or device right from its discovery to concerned regulatory bodies for seeking their FDA approval. The prime benefit of this process for the sponsors is that their efforts of staffing the workforce for accomplishing these studies in-house is now at ease with the CRO. So, here are some Do’s and don’ts to consider while connecting with a potent CRO to suffice your clinical study requirements –
Check the experience and portfolio –
While you step out to evaluate tons and tons of CROs available in the market, your first and the foremost selection criterion should be to check their experience as well as portfolio. Do not just browse through their experience blindly, but make sure to check their experience applicable to your therapeutic area. You may question them regarding the clinical trials they have conducted for the therapeutic entities pertaining to your field of research.
Are they financially stable?
Financial stability is most important for any bioanalytical laboratory to suffice their clinical trials requirements of the drug development process. By virtue of their working ethics, CROs are considered to be amongst all those who are high-risk evaluators. It is so because their work is mainly focused towards developing products that need not necessarily acquire marketing and commercialization approval. So, avoid connecting with those CRO’s who do not find themselves to be financially stable to justify their worth for your organization. What you may rather do is that ask them for how long have they been into the business and then go on to check their portfolio.
Have a round of their infrastructure –
Appropriate CRO infrastructure is very important for sufficing all your project requirements. Consider connecting with a CRO that has adequate facilities including staffing support so that they can handle and execute your project requirements aptly. You can even ask for the available software to keep a track of how your project is progressing further. Make sure that their clinical information system is structured and organized well. For a CRO to comply with your GLP requirements, it is important that they strictly adhere to the 21 CFR Part 11 compliance norms. Check whether they have access to investigator sites as this information might prove to be instrumental for you to obtain productive sites with a proven track of obtaining valuable services and high quality patient health information.