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12 BioPharm International May 2022 eBook www.biopharminternational.com studies for food, drugs, medical prod- ucts, and devices. To ensure quality, the guidelines require specif ic docu- mentation to be kept on several key areas, including laboratory staff, facil- ities and operations, equipment, test and control articles, conduct of study and archiving of data, and records and specimens (6). Similarly, good manu- facturing practice (GMP) guidelines ensure that pharmaceutical products used during pharmaceutical develop- ment and commercially are produced according to the standards put in place by FDA following approval (7). As the amount of outsourced R&D continues to grow, it becomes import- ant for sponsors to ensure that the CROs and contract development and manu fact u r ing organizations they do business with are compliant with GLP, good c l in ica l prac t ice, a nd GMP. As any company knows who has been down this road, the most expensive study is the one that needs to be repeated. It is imperative, there- fore, for sponsors to establish, manage, and monitor their quality control and QA systems, as well as establish bul- let-proof documentation procedures to provide high-quality products and ser- vices that fully satisfy customer needs and expectations. One of the primar y concerns for sponsors who outsource their research is losing control of quality and time- line, as some contractors may require more time to master assays and mod- els for studies. One way to mitigate this problem is to select a preclinical partner with the appropriate experi- ence; preferably one the company has worked with in the past or which has a solid reputation in the field (8). Both parties benef it from strong com mu n ic at ion f rom b ot h side s. Transparency matters, too. For exam- ple, when a CRO is inspected when it receives an FDA Form 483 or a warn- ing letter, the sponsors of their proj- ects need to be informed quickly in case it impacts their studies (2). Before outsourcing its resea rch, a sponsor needs to be sure that the capabilities and qualif ications of the CRO will be able to meet the regu- latory requirements applicable to its product. Audits conducted during the project will ensure that the ini- tial standards are maintained and that reg u lator y requirements a re being met (2). During the pandemic when travel was limited, remote audits of research studies became more prev- a lent, t hough t he success of t h is method depends upon how good the technology is and how prepared both parties are in making documentation available electronically (9). W h i le e v er y CRO is e a g er to increase their client base, sometimes t u rning away business is the best route, especially if sponsors are strug- gling financially. When a sponsor cuts corners to make their budget work, and the proposa l is, therefore, not appropriate from a compliance stand- point, going forward can ultimately risk a CRO's reputation. HOW IMPORTANT IS GEOGRAPHY? Being located next door to one's CRO used to be a practical necessity, but the situation has changed. Most biophar- maceutical companies would rank prox- imity low on their list of reasons for partnering with a CRO (10). With that said, the COVID-19 pandemic showed the pharmaceutical industry how vul- nerable it is to disruptions in supply chains (11). The COVID-19 pandemic also put the pharmaceutical industry in the spotlight, sparking increased levels of interest in the drug development pro- cess. The successes in moving vaccines and drugs to market would not have been possible without the help of CROs. Given the globalization of today's economy, the ideal company for a spon- sor to partner with might be one that has local facilities, a global presence, and a proven ability to meet the reg- ulatory requirements governing their product. Furthermore, for sponsors who are at the cutting edge of science where regulations may be limited or absent, selecting a CRO with experience in developing similar products successfully is not just important but essential. Still, technological advances, the relative ease of transportation, the complex oper- ations of full-service CROs, and the selective nature of niche CROs make location less and less of a deciding fac- tor. Though there is still an element of convenience and time savings for some CRO clients who prefer to keep their partners close by and be a part of the oversight of their studies (2). The choice of partner is usually driven primarily by regulatory needs. In China's research market, where it is not easy to export human samples or share data, sponsors are usually forced to establish partnerships in that country to complete their work. If a product is des- tined for Europe, a sponsor will naturally look toward a European CRO to partner with because they would be more famil- iar with the regulatory framework (2). HOW COORDINATION IS NECESSARY FOR ANY WINNING PARTNERSHIP As previously mentioned, it's important to set expectations at the beginning of the relationship. No one enters a marriage thinking that the next 50 Partnerships for Outsourcing Development When issues surface, it is important to be able to resolve them quickly and get on with the study because time is money in research.