Outsourcing Clinical Trials
The Five F’s: Traits to Consider When Choosing Your Next CRO
Experience, teamwork, and industry know-how are key qualities when outsourcing clinical trials, but it might be easier to consider the five Fs when trying to choose the best CRO; forward thinking, fast, familiar, fit, and flexible.
CROs with strong leaders who empower decision-makers at every level can help bring inventive ideas to fruition. Allowing experienced employees the authority to push creative strategies forward removes bureaucratic bottlenecks and creates a faster, streamlined process. Thinking outside the box takes courage, but when you hire a CRO with forward-thinking members, you can trust they are working in your best interest, not just following the crowd.
Safely getting your product to market is a company’s top priority and your CRO should share your enthusiasm as well as your sense of urgency. Ask if your CRO can quickly respond to questions that may arise in between scheduled discussions. A smaller, niche CRO can often assemble the expertise of all employees, including founders, to quickly meet your deliverables. A CRO that is able to pull from the cache of all team members can help you anticipate issues and stay ahead of deadlines.
Bigger isn’t always better. Sometimes it’s more effective to choose a CRO that fits your unique needs. You want a team with whom you can build lasting, collaborative relationships and who has a strong understanding of the challenges you face. A good fit means your CRO can quickly assemble team members with just the right experience to fit the requirements of your study. Choose a team that can scale their services up or down to meet the needs of your specific project — a thought partner, if you will, to really listen to your company’s vision and help turn it into a reality.
Make sure you choose a team that’s been around the pharmaceutical block — that they have quite a few years of experience in developing and managing clinical trials. You want to ensure the team can complete your study with impeccable monitoring, data collection, and analysis. So the team you choose should be familiar with all phases of clinical development, from strategic consulting to postmarketing studies and patient registries.
We’ve heard the terms study data tabulation model (SDTM) and clinical data interchange standards consortium (CDISC) when talking about standardized data for clinical trials. Yes, familiarity with standard data formats is still important when selecting a CRO, but these tools are not the only ones in the shed. You want a CRO that considers CDISC and SDTM for every database but that’s flexible enough to work with any format you provide. Find a CRO who has an effective data warehouse or repository to convert and import your data, regardless of file type.
Choosing a CRO has an enormous impact on your study’s future. To set yourself up for success you need a company with a flexible management structure that is devoid of unnecessary layers of bureaucracy. A company that listens to your needs as the study evolves with the ability to promptly react by making top level decisions that create efficient solutions and cost savings. A company with industry experience to help you navigate the hurdles of an FDA submission. Basically, a company that is passionate about your study and will be there with you from Phase I to Phase IV. It just so happens that PharPoint Research fulfills all of these qualifications and more.
PharPoint Research is excited discuss your next clinical trial. Visit our website or email firstname.lastname@example.org to learn how we can help your study reach peak performance.
Attachments: Consider the ‘Five Fs’ When Choosing a CRO