Small but mighty: here's how biotechs can nail their data management

    Over the last year, biotechs have introduced sought-after treatments and vaccines during the pandemic. Here's how they can fine-tune their data management.


    The past year brought small biotech firms to the forefront as they continued to bring treatments and vaccines to market during the pandemic. Unsurprisingly, as a result, they’re attracting significant and growing investment. But as these exciting young companies emerge from the lab and start to prepare themselves for commercial prosperity, it’s important that they start to think and work - and data management - in more structured ways.

    How to do data management right

    With their eyes on the prize of acquisition by a large brand, it’s never too early for biotech startups to get their data in order, for instance – so that it’s easy to access and has good integrity, lending itself to due diligence processes down the line. Here are some things to keep in mind when tackling data management.

    Start with a single, central source of truth

    Rather than leave Quality and Regulatory systems to their CRO partners, it’s a good idea for biotechs to start as they mean to go on, capturing everything from training records to QMS data, raw materials information, and health and safety data in a reliable, single, central repository, instead of across a patchwork of spreadsheets and manual systems.

    Applying rigor from the start makes sense for so many reasons. Bedding in good processes and data housekeeping from the early days creates good habits and will save a lot of work later. It also saves people’s valuable time, will look good to potential investors or buyers and, above all, shows a commitment to public safety, transparency and traceability.

    It is for all of these reasons that regulators and independent consultants are advising that biotechs maintain good data management practices from the beginning, adhering to the latest ISO IDMP data standards for capturing, classifying and reporting on regulated product detail. As well as imposing good internal discipline, it opens up a host of other potential process-based benefits, not least more fluid collaboration to tackle world health challenges.

    Don’t put off today what you’ll have to tackle tomorrow

    Conversely, if biotechs put off formal structures until some future point, the backlog of effort and content that will need to be converted will only grow and become more onerous. Even, or especially, now there is a strong driver for systematic track and trace capabilities so that drug and vaccine producers can monitor their products in the market. And using spreadsheets or relying on bigger partners to do this for them is to put off something they’ll have to get on top off one day. No company wants to fall foul of Pharmacovigilance (PV) or Corrective and Preventive Actions (CAPA) requirements, or broader regulatory or validation expectations, because they didn’t have the right systems or processes in place.

    Incidentally, many of these points will apply to medical device manufacturers too – as small companies typically, which are less used to data rigor compared to large pharma, for example. These entities too will need to up their game when it comes to data organization and management, especially with plans to bring device UDI traceability down to the component level.

    Encouragingly, it’s easier now than ever to bring everything together and structure it all in one place - without the need for a massive IT capability in house. The ability to run everything in the cloud makes light work of the transformation, with the option of having someone else look after everything.

    Published on    Last updated on 21/07/2021

    #Life Sciences, #Data Management

    About the author

    As Global Strategic Accounts Consultant at Amplexor Life Sciences, based in the UK, Ian Crone is responsible for understanding client challenges and working alongside customers to identify optimum global solutions - a role involving international travel and long-term customer engagement. His background is in chemical engineering – the subject of both his university degree at Strathclyde University in Scotland and the first 14 years of his career, at Unilever. Over the two decades since, Ian has been involved in the chemical and pharmaceutical industry, from every angle of drug development, for the biggest names in life sciences. He has been involved both from an industry and technology supply side, in roles at Oxford Instruments, BioStorage Technologies and Samarind. Before joining Amplexor, Ian spent a decade at biotech advisory firm IAC Global Consultants, helping biotech companies build bridges with large pharmaceutical and chemical companies.