Globalization White Paper





Selecting the Optimal CRO


Why Partner with a CRO?

Because the world of product development is getting more complex. Because time to market is critical. Because regulatory issues grow more intricate by the day. Because R&D requires more of your budget at a time when every dollar and every Euro counts.

CROs offer pharmaceutical, biotechnology and medical device companies the resources, skilled workforce and research expertise to conduct high-quality clinical trials in a manner that's streamlined, efficient, and cost-effective. Today, CROs are partners in the drug development process, helping clients address everything from recruitment of participants to data-collection and analysis, from clinical trial planning to regulatory filing.

For a relationship so close, it's important to choose the right partner. Research sponsors need a CRO with whom they can communicate closely and honestly, with whom they can work through bad news as well as good. The CRO-sponsor relationship is one of shared vision, complementary expertise and trust. The CRO's team should understand the demands of your market, seeking ways to make each clinical effort more cost-effective, thorough and timely.

The right CRO is recognized for its professional approach by clients, regulators, even competitors. It subscribes to ACRO's Code of Ethics and its employees comply with rigorous U.S and international regulations and Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines. Its commitment to patient safety and research quality should be uncompromising.

Your CRO should provide regulatory expertise appropriate to a product's unique clinical approach and market targets. Studies should be paired with stringent quality assurance procedures and detailed product management, to make sure deadlines are met and budgets followed. Reporting should be clear, thorough and accurate.

Simply put, the optimal CRO streamlines the complex process of taking potential new medical treatment from laboratory to market – safely, efficiently and cost-effectively.

 

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