The way pharma and regulators collaborate to bring safe new therapies to market is ripe for transformation but one major bottleneck slowing progress here is the onerous documentation process.
The process of moving from paper to digital with the advent of electronic standards (eCTD) has improved certain aspects of the filing process – such as version control and the ability to copy chunks of data with greater ease – but this is only scratching the surface of what’s possible with automation.
Pharma has only just begun to exploit the full potential of eCTD.
A new paper from Reuters Events Pharma and DXC explores the progress of automation technologies to drive more efficient and error-free processes as well as faster time to insight and approval.
The paper, Digitizing regulatory affairs: The future of automation, examines how Pharma’s regulatory functions are already streamlining their internal processes to prepare for broader automation, how the industry is piloting new workflows and how it is planning to exploit AI tools to drive further transformations.
Near term, pharma can apply automation to routine processes that are typically offshored to service companies with rapid ROI, and it can realise quick wins with more content automation such as protocol summaries.
Further out, there is enormous scope to reduce handoffs in the documentation creation process, the number of people involved, and the time taken as internal processes are aligned and automated.
Less friction on the exchange of documentation will create more time for pharma’s regulatory function to cut operational legwork and more time engaging with scientists and health authorities on meaningful knowledge exchange.
Ultimately, automation will be key to heavily digitalized trials that sponsors and regulators review in real time. Such automation efforts would be part of wider opportunities to automate the identification of future indications or routinely run synthetic trial control arms.
A range of challenges
But significant challenges remain. Inconsistent eCTD adoption globally is a big impediment, along with friction from internal processes.
The execution of master data management plans must go right. The talent needed to create, test, validate and deploy the end-to-end document automation processes is going to have to be cultivated. So does a ‘machine-first’ mindset that accepts the primacy of automated over human processes.
Much of the most promising medium to long-term potential to automate regulatory interactions also depends on the emerging generation of often unproven AI tools.
But the direction of travel is clear. A series of pilots being developed or run today promise to drive end-to-end process improvements in specific therapeutic areas that should serve as proving grounds for wider adoption.
The ultimate destination of a dynamic regulatory system in which stakeholders evaluate data in real or near-real time and bring better outcomes to patients and payers faster, while still some way away, is in sight.
Click here to read the full paper.
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Primary Event: WORKSHOP: Digitizing regulatory affairs: The future of automationPrécis: Post pandemic, pharma and regulators are both working to accelerate the transformative power of electronic filing Premium`: Freemium`: Channels: Access and EvidenceTags: Regulatory BodyOriginal Article
