January 2022 was the 'Go-Live' for the EU Clinical Trial Regulation and CTIS. Steve Gunnigle shares some insights.
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GCP impact on clinical operations
GCP impact on clinical operations
We present an expert-backed view on the revision to Good Clinical Practice (ICH GCP E6 R3) and the likely impact of these changes on clinical operations.
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Optimising external engagement in the digital age
Optimising external engagement in the digital age
Technological developments and the ever-increasing breadth and depth of new information and evidence being generated have driven many life sciences...
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Digitisation in Medical Affairs
Digitisation in Medical Affairs
Artificial intelligence (AI) and broader digitisation are now key areas of focus and investment for many biopharma companies. While use cases have been...
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Future of Regulatory Affairs
Future of Regulatory Affairs
We present a series of opportunities and challenges for biopharmaceutical Regulatory Affairs. Underpinning the preparations and response is the need...
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Reflections on iEGP
Reflections on iEGP
Delivering timely and robust evidence to external stakeholders is increasingly critical, as companies now face complex challenges in meeting the diverse...
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Data governance in a Zettabyte world: implications for R&D
Data governance in a Zettabyte world: implications for R&D
In a world characterised by unprecedented generation, storage and utilisation of data on a massive scale, the biopharmaceutical industry has been compelled...
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Harnessing AI to create economic and patient value
Harnessing AI to create economic and patient value
Across biopharma, many companies are jumping on the AI bandwagon in an effort to drive innovation and increase productivity. In a nascent, fast-moving...
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Outsourcing strategy for scalable growth
Outsourcing strategy for scalable growth
Target Clinical Development outsourcing operating model.
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Digitising Medical planning
Digitising Medical planning
Digitising of Global oncology Medical strategy plans across assets.
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Medical Affairs KPIs
Medical Affairs KPIs
The purpose of this paper is to describe how effective Medical Affairs KPIs can be developed as straightforwardly as possible, and to present key elements that organisations should consider in their own KPI dashboards.
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Medical operations of the future
Medical operations of the future
As Medical Affairs organisations continue to evolve, the 'Medical Operations' or 'Medical Excellence' group is becoming increasingly important. This paper explores how Medical Operations groups can best evolve to...
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DCTs: achieving our ambition
DCTs: achieving our ambition
Decentralised clinical trials (DCTs) present a biopharmaceutical company with a series of opportunities and challenges. We highlight the challenges and examine...
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Accelerating the pathway to launch for a breakthrough oncology asset
Accelerating the pathway to launch for a breakthrough oncology asset
Our client needed a partner to help them navigate the journey to launch and successfully bring their product to market while creating a model for future launches across the organisation.
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Everyone deserves better health
Everyone deserves better health
Learn how we used our proprietary advanced analytics, hyper-targeted media, and digital efforts to help a P2-positioned brand achieve a 30% increase in NRx and a 10-point gain in market share.
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It's time to start taking things non-personally
It's time to start taking things non-personally
Learn how we used our proprietary advanced analytics, hyper-targeted media and digital efforts to help a P2-positioned brand achieve a 30% increase in NRx and a 10-point gain in market share.
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Let's do launch
Let's do launch
Learn how we used data-driven intelligence and strategic scenario planning to deliver a flawless launch for a new biologic, transitioning our client from peripheral player to category leader.
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Does your brand need another bounce?
Does your brand need another bounce?
Learn how we used advanced analytics and relevant insight to lift a steadily declining legacy brand to its highest growth rate in NBRx share in 5 years.
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Had enough media mediocrity?
Had enough media mediocrity?
Learn how we used advanced analytics to find insights that dramatically increased a client’s campaign performance and increased ROI 7:1.
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Dramatically improving audience quality and campaign ROI with LCI targeting data overlays
Dramatically improving audience quality and campaign ROI with LCI targeting data overlays
MAVENCLAD (cladribine) positions itself as the oral of choice for first switch in active RMS.
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Infusing innovation with emotion to launch a one-of-a-kind product
Infusing innovation with emotion to launch a one-of-a-kind product
Naloxone was being launched as a branded product in a complex generic market.
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Expanding the brand footprint into paid social
Expanding the brand footprint into paid social
MAVENCLAD (cladribine) needed to find a way to stand out from the competition and expand paid social presence beyond Facebook and Instagram.
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Challenging engrained treatment behaviours: Disrupt the Decline
Challenging engrained treatment behaviours: Disrupt the Decline
Despite clinical acceptance of the efficacy of long-acting injectables (LAIs) to provide prolonged stability for people suffering from schizophrenia, they still only make up about 13% of the market.
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Real-world data fueled media: Finding and exploiting the subtle factors that influence clinical decision-making
Real-world data fueled media: Finding and exploiting the subtle factors that influence clinical decision-making
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Swiftly and purposefully establishing a meaningful connection with healthcare professionals (HCPs), patients, payers, influencers, and stakeholders
Swiftly and purposefully establishing a meaningful connection with healthcare professionals (HCPs), patients, payers, influencers, and stakeholders
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Building a community and a reputation
Building a community and a reputation
Learn how an award-winning scientific exchange programme keeps a clinical community up to date with advances in the therapy area, while also elevating standards of care and building our client’s reputation.
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Making way for a new brand
Making way for a new brand
Learn how an award-winning omnichannel programme challenged the status quo, drove a paradigm shift, and boosted early sales.
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Global evidence generation strategy
Global evidence generation strategy
Development of an evidence-generation strategy and expanded LCM opportunities to drive competitive differentiation aligned to stakeholder market-value drivers.
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Portfolio buy and build
Portfolio buy and build
A thorough process to assess and validate future development and acquisition targets, optimising portfolio and disease area strategy and aligning key stakeholders to plan.
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Making it happen where you are
Making it happen where you are
Learn how a global educational programme can be successfully activated in local markets through targeted engagement, insight-driven planning and some healthy in-team competition.
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Minding the gaps
Minding the gaps
Learn how gathering internal and external community insights transformed an integrated evidence-generation plan and maximised product differentiation opportunities ahead of launch.
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Readying the community for change
Readying the community for change
Learn how a multi-interventional educational campaign elevated the standard of care and prepared the clinical and patient community for a new treatment option.
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Animated back to basics
Animated back to basics
Learn how a highly visual animation used a novel analogy to break down and explain the science behind the disease, ensuring a wide audience base can understand the value of a new treatment.
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Pipeline prioritisation, positioning and planning
Pipeline prioritisation, positioning and planning
A robust, cross-functional approach to set the strategic direction for pipeline assets and their target indications in the context of an existing portfolio.
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Are you ready to transform the potential of your asset or brand?
Are you ready to transform the potential of your asset or brand?