Every biotech company conducts hundreds of scientific studies on the path to submitting their results to the FDA for approval. Whether it be for efficacy, toxicity, potency, purity, stability, or all the rest, these experiments create a huge amount of data.

These ongoing studies, particularly in the methods development phase, constantly shift and reorient based on the findings, creating even bigger data challenges. In addition, progress must be tracked, results analyzed, changes updated, and project results maintained.

The final result of these efforts is a completed eCTD FDA submission.

Managing methods and Process Development (Drug Substance & Product), Analytical/QC testing, MS&T, and Pilot Production can be a hectic experience as the race to meet milestones and funding targets is real.

Even with an organized approach, the focus on results wins out over the administration of the effort. To keep the spending “burn rate” low, most at this stage are under-resourced, with staff wearing multiple hats – especially management. The typical outcome of the study results is a hodgepodge of data in numerous stages of submission readiness.

As the first IND submission timeline approaches, there’s a mad dash to uncover all the data. Unstructured ELN entries, unmatched CDS content, uncharted Spreadsheet info, missing LIMS data, and misplaced results from staff no longer with the company, all rear their ugly heads at the worst possible time.

Many try overcoming these challenges by hiring teams of hourly Contractors. They’re brought in at great expense working with management to unearth and piece together the study data needed for the submission. This approach is costly and very time-consuming.