CONTENTS


Contents 7.


Reflections on how best to ensure we can be successful through the pandemic and into the future Darrell Panich, president of Ceros Management and Advisory, discusses how the pandemic has emphasised the need for well-being in the workplace


10.


Artificial intelligence for medical writing, part two: transparency, flexibility and control Dr Barry Drees, senior partner at Trilogy Writing & Consulting, on the partnership between person and machine


12.


When you need to move to another vendor: what to consider from the perspective of a QA professional Q&A with Karen Hue, head of quality and GxP compliance


16.


How to shorten the comparator sourcing supply chain and improve efficiencies Clinical Services International (CSI) recommends a bespoke sourcing strategy to ensure your trial runs successfully


20.


CRO, CRO, wherefore art thou, CRO? Audrey Rossow, senior director, clinical operations, at Pulmatrix, on finding the right contract research organisation


24.


Clinical trials are changing, along with support requirements Avantor Clinical Services on the trend for customisation of clinical trials


26.


Going agile: how it can improve clinical trials David Larwood of Valley Fever Solutions takes an agile approach to clinical trials


4 | Outsourcing in Clinical Trials Handbook 45. 31.


Blockchain and the drug supply chain Frank Leu of Novapeutics discusses a pilot programme for merging two chains to efficiently power forward drug developments Novapeutics


34.


Empower your next study with a truly unified system Get the lowdown on Axiom Metrics’ e-clinical solutions


39.


Smart packaging to improve medication adherence during clinical trials Smart bottle caps and blister packaging are transforming the clinical trials space, says Arul Joseph, senior director, pharmaceutical development and clinical supply chain at Avanir Pharmaceuticals


42.


How decentralised trials make research more accessible and inclusive for participants and sites Sinéad Callinan, executive director of delivery EMEA at THREAD, on how to increase trial participation among under- represented groups


Harnessing AI to revolutionise study design and patient compliance: where will we be in five years’ time? José Manuel Ordoñez, therapeutic area leader in clinical operations for onco- haematology studies at Roche, on the benefits of using AI in clinical trials


48.


CMDRs hold the key to expediting drug development. So what’s holding the industry back? Mark Wheeldon, chief executive officer at Formedix, on the current barriers to progress in clinical trials


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