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With industry regulators urging pharmaceutical companies to move to a risk-based approach for clinical trials, TransCelerate (a pharmaceutical industry body) developed industry-model guidelines for targeted, risk-based clinical trial management and monitoring. Risk-based Management (RbM) means pharmaceutical organisations can realise greater operating and cost efficiencies, increased compliance with regulators, improved data quality and ultimately higher levels of patient safety.

Our client, a large, global pharmaceutical organisation had already started a change programme to adopt RbM and had ambitious targets to increase the number of studies using the new approach. However, the programme was stalling. Current capabilities and cultures had not been considered and there was resistance to the change amongst employee groups. They needed to take a different approach to the programme to make it stick.

Using our industry experience, we partnered with our client to bring fresh perspective and breath new life into the programme. We developed a holistic change management strategy which focussed on managing stakeholders and resistance, mobilising sponsors, compelling communications and interactive learning, to engage, inform and inspire those impacted.

Our solution

  • We created a sponsor coalition, demonstrating the importance of the change and that leaders of the organisation were behind it.
  • We created a champions network of people who were highly-educated about the new ways of working to act as a mouthpiece for the programme, advocating it within their functional/therapeutic areas.
  • We developed a highly-targeted communications plan to inform and engage, including:
    • A sponsor video, followed up with a monthly Talking Points – keeping sponsors up to date with key information to share with their teams;
    • An introductory animated video of the programme – tailored to specific roles – aligning into specific behaviours and new ways of working.
    • Roadshows where colleagues could talk to the experts, experience demos, and see how everything fitted together and how it might impact them.
  • We created a learning path for the organisation so that people could easily identify the learning modules they needed to do and when they needed to do them.
  • We designed a series of engaging, two-stage learning programmes including, interactive e-learning modules, followed up by f2f courses designed for specific roles and functions.

The differences we made

  • Informed and supportive sponsors that were highly active and visible
  • An active, engaged champions network supporting study teams as they get to grips with RbM
  • Awareness for RBM has gone through the roof – it’s now live and perceived as THE way of working
  • Increased understanding of impact and benefits with 11 e-learning modules rolled out to 5,000 people, globally
  • Interactive learning packages that look and feel different to the norm
  • 100% of roadshow delegates enjoyed their experience and found it useful. Comments included – “Good opportunity to meet people from different functions”, “Fantastic event – I learned a lot”, “Will grab this idea and advertise my own projects in the same way.”

If you’d like to get in touch with us to talk about your organisation’s business change needs, give us a call (+44) 0845 608 0104, or send us an email and we’ll get straight back to you.