5 Reasons You Should Outsource Your Phase 1 Clinical Trial
Posted by WCCT Global on February 8th, 2021
If your biotech start-up is advancing to the early clinical development stages, chances are you’re looking to start a Phase 1 clinical trial in the near future. This is one of the most critical parts of developing a product and can set the pace, standards, and trajectory for the rest of your clinical development program. While likely to be the shortest and least expensive stage of development, it still represents a substantial financial and resource commitment. If your company does not have the resources or necessary experience in-house, it is a far better idea to outsource the Phase 1 clinical trial to a contract research organization (CRO). After all, if you don’t do it right the first time, you’ll have to make time to do it over.
Optimizing Start-Up Time
A CRO with Phase 1 clinical trial experience likely already has a team of personnel that handles the functional tasks of a start-up phase, increasing efficiency and reducing the time it takes to produce deliverables. This could include pre-screening, participant wait-listing, and conducting flexible screening activities. They can create source documents, draft an Informed Consent Form, create any necessary participant-facing materials, and more.
Performing Proper Participant Recruitment
Recruitment plans, such as establishing clear criteria for inclusion and exclusion, are essential to a successful Phase 1 clinical trial. However, not all study designs are created equal, at least in the eyes of participants, and they might have well-informed expectations for stipends, procedural requirements, or transportation support. Without a CRO, you’ll need to manage the study design, standard of care, recruitment strategy, and any other concerns without assistance, which is a challenge if you don’t have experts within your company. If you need to perform an ethnobridging study, participant recruitment can be particularly difficult, as you might not have access to dedicated outreach and recruitment team within specific populations.
Effective Risk Management
Because no two studies are the same, it’s vital to maintain an objective method of evaluating the potential risk that is repeatable and documentable. Stakeholders must be identified, appropriate categories of risks must be created, risks must be determined, and more. A CRO with Phase 1 experience has performed these actions before and has the necessary training to assess risks.
Proper Equipment and Resources
For a successful trial, your company needs the right equipment and resources. Do you have phase 1 clinical trial units for overnight studies? Do you have sterile rooms? A laboratory? The ability to perform special procedures necessary for the trial? If not, it’s best to outsource to a CRO with the proper facilities and equipment. Plus, if the CRO does not have it, the CRO likely already manages a list of qualified vendors with whom they can sub-contract, taking advantage of other specialists that can improve your study. Plus, a CRO will likely already have staff with clinical trial experience and know how to recruit more staff if needed.
Research Services
Choose a CRO that can also help you with research services, such as protocol development, medical writing, and regulatory support. There should also be arrangements in place for project and data management, clinical monitoring and biostatistics, and medical monitoring and safety. It’s essential to have experience in these for a successful trial to produce viable, actionable results.
About WCCT Global
WCCT Global is a full-service contract research organization (CRO) catering to the pharmaceutical, biotechnology, and medical device industries. With specialized regulatory and clinical professionals, WCCT offers an innovative, collaborative, and agile approach to every program delivered. They offer their partners a 75,000-square-foot clinical pharmacology unit (CPU) with 180 beds, perfect for Phase 1 clinical trials. They also offer an on-site, CLIA-certified and CAP-accredited Safety Reference Laboratory and a USP-797 compliant pharmacy. With extensive Phase 1 clinical trial experience, WCCT’s areas of expertise include First-in-Human, SAD/MAD, PK/PD, BA/BE, and devices. They focus on Ethnobridging, First-in-Human, infectious disease and vaccines, ophthalmology, women’s health, and nicotine and tobacco clinical trials and are an industry leader in Asian Ethnic Bridging studies, specifically with Japanese participants.
Sponsor a Phase 1 clinical trial by partnering with WCCT Global at https://sponsor.wcct.com/
Original Source: https://bit.ly/3cSfEug
