What To Know
- By managing the trials centrally, goals can be exceeded and the enhanced infrastructure enables process accommodations and risk mitigation to be implemented on a rolling basis as the ebbs and flows of the current environment continue to shift.
- Consultation on protocol development allowing sponsors to utilize our network in order to help them build the study protocol on what will work when in practice, ensuring it is compliant with FDA policy.
ClinEdge and BTC Network, portfolio companies of ClinX, announce today over twenty of its experienced vaccine centers of excellence have been selected for several of the major pharmaceutical company programs for COVID-19 vaccines initiating this summer and fall. In addition, a number of the ClinEdge & BTC Network sites are being considered for dozens of upcoming vaccine programs preparing study start-up activities.
Site selection is critical in any study but more critical than ever to ensure COVID studies meet historical records of approvals and require vaccine centers of excellence. Our dedicated research health and research facilities have proven staff, policies and processes around hybrid study structures in order to achieve enrollment and safety” said Christian Burns, President of ClinEdge & BTC.
ClinEdge & BTC Network sites are in high demand during this time because of our facilities’ significant vaccine experience, having contributed to more than 45 large programs within the past two years across a range of vaccine programs (which includes 17 different sponsors in the past year). During the pandemic, the networks combined expertise to launch a new offering specific for COVID-19 vaccine studies. This offering enables dedicated biotech and pharmaceutical companies to have an integrated solution that can fast track site start-up and enrollment at our sites. Together, the networks provide access to hundreds of thousands of potential volunteers to test vaccines against the pandemic.
ClinEdge & BTC integrate and centralize operations while implementing patient education and recruitment services. This allows the sites to focus on enrolling subjects quickly while maintaining an emphasis on patient safety and data quality. ClinEdge and BTC also have the ability to conduct hybrid clinical trial offerings, including support for home health care and remote monitoring. These services help ensure sites are able to reach as many potential subjects as possible.
Site Network Services & Opportunities for COVID Vaccine Pharmaceutical & Biotech Studies:
- Access to ClinEdge & BTC’s large, global network of qualified research centers
- Study start-up coordination managed centrally for all site locations
- Study start-up goal is enrollment ready within several weeks of receiving initial regulatory documents
- Development of a comprehensive recruitment campaign for each site
- Experienced Study Patient Navigators serving as a single point of contact for study volunteers
- Home Health Care management options allowing studies to be conducted in the patient’s home while managed by the local site organization
- Visit assessments, including the ability to conduct routine study protocol visits remotely
- Electronic source system technology that manages all study volunteer data
- Study volunteer recruitment and travel services enabling the patient-specific study roadmap to have each step coordinated decreasing the chance of COVID exposure and increasing the likelihood of participation
- Consultation on protocol development allowing sponsors to utilize our network in order to help them build the study protocol on what will work when in practice, ensuring it is compliant with FDA policy
All of the network sites have access to ClinEdge & BTCs Risk Mitigation and Recovery Plans to ensure the successful execution of clinical trials under FDA guidelines. In present studies, our sites have over 100% of volunteers pre-identified prior to First Patient First Visit (FPFV). Prior centralized vaccine studies in addition to COVID-19 include Influenza, Shingles, C. difficile, Meningitis, Herpes Zoster, Pneumococcal, RSV, HPV, Cholera, Ebola, and Smallbox.
ClinEdge and BTC Network highly recommend the centralization of COVID-19 study conduct into an experienced network to maximize speed and quality of data. By managing the trials centrally, goals can be exceeded and the enhanced infrastructure enables process accommodations and risk mitigation to be implemented on a rolling basis as the ebbs and flows of the current environment continue to shift.