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The regulatory submissions process can feel like the passing of a baton from R&D to the regulatory submissions team. That team then massages data to fit the formats required for agency submissions portals. But efficient organizations see submissions as not a handoff but a partnership.
The importance of a strong submissions strategy in regulatory submissions
A strong submissions strategy starts on day one, with a digital foundation that efficiently captures and reduces errors, provides data provenance and traceability and organizes approved data for easy discovery.
It costs $1.1 billion, on average, to develop a new drug, according to an investigation published in JAMA. Moving quickly brings advantages: One McKinsey study found a 6% market share advantage for being first to market; earlier to market also means more time to explore additional patents. So an efficient approach matters.
Yet despite the high stakes, many teams find themselves facing avoidable last-minute delays: Sloppy record keeping creates errors and costly rework. Many errors could be avoided by implementing transparent, digital processes much further upstream. Regulatory submissions, good laboratory practice and the integrity of scientific research all require trustworthy data. In part, that trust is based on internal audits. Any time someone follows a standard operating procedure for a test or a process, someone else checks their work and signs off on the results.
In theory, if questions come up near the regulatory finish line, submissions managers need only return to those audits and signatures for the necessary paper trail. In practice, without meticulous lab organization for each test, managers face tedious phone calls tracing hundreds of tests from years of experiments.
Addressing common delays and challenges
Data that is poorly contextualized, hard to access and stored across systems that don’t talk to each other causes tangled audit trails that make submissions difficult. “Did you sign off? Who did?” “The sign off is in SharePoint somewhere? What month would that have been uploaded?” The answer is usually there but finding it — or redoing the work — can mean costly delays.
When that happens, systems that seemed “good enough” day-to-day are no longer good enough to stay competitive. For efficiency’s sake, organized labs need a roadmap for digitally automating standard operating procedures (SOP).
Implementing electronic SOPs for regulatory submissions
First, a strong electronic SOP roadmap must include strategies for finding and organizing data for submissions. Enterprise systems abound to help labs standardize processes and organize data and instruments—like Electronic Laboratory Notebooks (ELN), Laboratory Information Systems (LIMS), Manufacturing Execution Systems (MES) and Enterprise Content Management Systems (ECM). But these systems are often poorly integrated with the lab workflow. Data silos mean that manually extracted data for reporting and submissions often lacks context to qualify the results.
To solve this disjointed ecosystem, systems and customers should move towards clear digital standards. F.A.I.R. is an emerging principle for how digital systems should expose data for reuse and system interoperability. Modern systems should develop to these principles to improve integration. In addition, system vendors should support Clinical Data Interchange Standards Consortium (CDISC) standards. CDISC is a consortium that creates standards for preclinical and clinical data, accepted by regulators for electronic submission. These standards can make it easier to enter data in regulatory portals.
Second, the electronic SOP roadmap must address the challenge of verifying data. With traditional paper SOPs, quality assurance teams review reports for both process compliance and data integrity. By fully digitizing the end-to-end workflow, labs can reduce QA overhead and inefficiency. Systems which support electronic SOPs can monitor compliance in real time, improving both efficiency and data quality. As the user is completing a test and entering data, the tool can check each step. If the e-SOP requires a balance check, the system can confirm that a smart balance of the correct type is online and has been recently calibrated and can then directly capture the weight from the balance.
Managing variations and exceptions
If the e-SOP requires the weighing result to be in a specific range of values to be valid, the tool can confirm this as well, alerting the operator of any deviation to allow for immediate corrections or commenting. Allowing for slight variations in an SOP is critical in the lab — sometimes things don’t go as planned, but the operator has a valid reason to proceed. In such cases, the user can enter an explanation for the variation or any corrective actions taken, which are then recorded in the audit log.
Often referred to as “audit by exception,” this approach reduces the work that the human auditor must perform. Rather than checking all steps, auditors can instead use exceptions and user comments to judge compliance. Electronic SOP systems that can monitor compliance, track deviations and allow for commenting should improve subsequent quality assurance reviews.
Finally, these systems can be secured with digital signatures per 21 CFR Part 11 and full audit trails to ensure data integrity and tamper prevention. Adopting these digital systems saves time for the QA team while improving data quality and traceability — and providing a clear audit record for regulatory agencies. Easily discoverable, validated data with a digital chain of custody should also be easier to assemble into the eCTD formats used by the FDA.
Moving toward a fully digitized workflow
As an industry, we are moving in the right direction with the current focus on connecting laboratory instruments with a fully digitized workflow. The advantages of improving data management are numerous—and they include making regulatory filings easier to speed time to market.
Organizations looking to boost efficiency — and to move from handoffs between teams to a more integrated partnership—should start building roadmaps now to integrate F.A.I.R principles and CDISC standards and to move towards electronic SOPs and an audit by exception approach. Then, instead of playing telephone and painstakingly tracing years of work, submissions teams will simply have the information they need at their fingertips.
Scott Weiss
Scott Weiss is vice president, open innovation at IDBS and is responsible for developing IDBS’ expanding network of technology and channel partners. He joined IDBS in 2004 and has held senior leadership roles in consultancy, product management and strategy. Prior to joining IDBS, Scott spent over 20 years in the pharmaceutical industry, where he led multiple drug-development programs from conceptualization to entry in clinical trials and has authored over 30 peer-reviewed scientific papers and patents. He obtained his PhD in Psychology from the University of Leeds, specializing in Neuroscience.
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