Preclinical
Vaccines are unique in the biologic space because they stand as a reaction, typically, to a human health crisis. They are sought to rapidly reduce the spread of infectious disease, and, as such, they require a deft, experienced hand to move through global regulatory agency scrutiny as efficiently as possible. DataRevive has proven capability to optimize IND packages to meet regulators’ requirements on the first submission, as reflected in our stellar track record of safe-to-proceed determinations for submitted IND applications. Our team is also expert in expedited pathways via Fast Track, Orphan Drug Designation (ODD), and Breakthrough Therapy designations, and can help you determine the best program design to facilitate rapid, quality development of your vaccine candidate.
Clinical Trials & Manufacturing
As vaccines demand the aforementioned additional level of speed and efficiency in their development as they stand to dramatically affect global human health, the clinical trial phase of development may coincide with the physical manufacturing of vaccines. This layered complexity is serviced well by DataRevive’s dynamic experience and understanding of clinical study execution and analysis, BLA preparation, writing and submission, and the right-fit CMC and GMP strategies. By meeting the trial and manufacturing needs of your vaccine, DataRevive will help you reach the market more efficiently.
Marketing and Safety Monitoring
The safety monitoring of vaccines demands an attentive approach to the post-licensure monitoring of vaccine safety as, sometimes, clinical trial sample sizes simply aren’t large enough to identify undesirable reactions to the vaccine itself. DataRevive is equipped to provide not only the post-licensure marketing and safety monitoring support required by pharmaceuticals; we have the knowledge to support your organization through the continuous monitoring vaccines must receive and the potential stoppages and delay in distribution and administration that may result.
