Protocol Drafting

We help clinical partners compose and then validate pre, peri and post-operative clinical protocols.

At the heart of evidence-based medicine are observational clinical protocols (“OP’s”).  Importantly, regenerative (personalized or precision) medicine implies separate OP’s for specific indications, procedures and patient cohorts.  The proper design of these protocols, and the collection/reporting/analysis of data collected against them in a verifiable manner, form the foundation of “real-world data” and “real-world evidence”.  (This white paper provides more information on the emphasis placed by regulatory agencies, payers, providers and patients on RWD and RWE.)

An exciting and important element of an RMCE is advancing modern medicine through the design, execution and ongoing improvement of OP’s specific to its specific patient-base.  With sufficient data, such OP’s will evolve into standards of care across a variety of indications.  The RMCE C/SAB, as well as Regen Med Network, are continually available to assist in the initial and modified designs of OP’s, as well as the establishment of relevant correlations among the OP-generated data with various standardized outcomes measurements.