Adoption and Use

The following individuals, companies, groups and organisations support the use of CORE Reference as follows:

Synequanon (SQN) are pleased to announce that they have incorporated the CORE Reference into their working practices and express our thanks to EMWA for developing this reference.

Angela Jennings
Director Quality and PI, Synequanon, Norfolk, UK

I want to express my appreciation of all the hard work and dedication that went into this project. This is a very valuable tool for MWs, facilitating CT data transparency. I have recommended its implementation to colleagues within and outside my company.

Raquel Billiones
Senior Director, Medical & Regulatory Writing, Clinipace Worldwide

I adopt CORE Reference.

Daniela Penn
Freelance Medical Writer, Medisis

We distributed CORE Reference to our regulatory writers within Lilly and added it to our writer’s resource library. It will be a good aid the next time we update our CSR template

David Clemow
Advisor Scientific Communications Strategy, Eli Lilly

We are developing a clinical study report template for our group. We are using CORE Reference as a source and are citing it on the template.

Janice Beck
Medical Writer, Cardinal Health

Trilogy fully endorses the use of CORE Reference. We plan to incorporate it into our working practices. We also want to commend the entire working party for developing this wonderful tool. It is a step forward for the industry.

Julia Forjanic Klapproth
Senior Director, Trilogy Writing & Consulting

ICON has found CORE Reference to be an invaluable resource for our clinical and regulatory writing. It is especially helpful in proactively addressing not only the redaction of the Clinical Study Report, but also the development of clinical study outcomes or basic results documents and Lay Person Summaries. It is an authoritative resource in the new era of CT disclosure.

Christine Barlow
Director, Medical Writing, ICON Clinical Research (UK) Ltd

A valuable tool for all involved in CSRs

Steven Walker
Director, St Giles Medical London & Berlin

We are updating our CSR template in light of CORE Reference, and a reference to this tool in our Medical Writing SOPs seems essential. This is definitely a valuable tool. Many thanks to the CORE Reference team, who provide us with the level of information we need to appropriately manage CSRs.

Corinne De Backer
Senior Medical Writer, Lincoln, France

We have found CORE Reference to be very useful and essential for work and we are currently in the process of incorporating its principles and recommendations in our internal standards and procedures. We are also pleased to announce that we have shared information about CORE Reference at the IV annual conference held by OCT “Clinical trials in and outside Russia” that took place in Moscow on the 14th of September 2016 (Slides available here).  The conference attracted a wide audience, including the representatives of pharmaceutical companies and two experts of local regulatory authorities (Drug Expertise Organization of the Ministry of Health of Russia and the Eurasian Economic Commission). The attendees were very interested in finding out about this project and CORE Reference recommendations regarding the different aspects of the CSR writing.

We hope this will help distribute CORE Reference in Russia. The conference programme and photo gallery can be found at:

https://www.oct-clinicaltrials.com/news/2457.

Many thanks for EMWA and AMWA help and support actions for medical writers around the world!

Eugenia Radkova
Medical Writer, OCT Rus

As a CSR-naïve freelance medical writer, I have recently reported a non-interventional study assessing quality of life. Although CORE Reference is a resource for interventional and not non-interventional studies, I was able to refer to it for many sections of my report. I learned that writers adapt the ICH E3 suggested structure and also to what extent and in what way it can be modified. In short, despite my first CSR being for a non-interventional study, I believe CORE Reference increased the quality of my product, and it certainly reduced my anxiety. I very much appreciate that the CORE Reference team decided to share this expertise.

Gerard Carot Sans
Medical writer, Freelance

Chiltern Medical Writing are delighted to have incorporated CORE Reference into our standard operating procedure (SOP). Thank you to the EMWA team for the hard work in developing this very useful resource.

Rebecca Farrar
Senior Director Medical Writing, Global, Chiltern

The CORE Reference is an excellent and thoroughly useful CSR writing tool. A team of Parexel senior writers have recently reviewed the CORE Reference alongside our current CSR template. We found it an excellent resource for adding instructional text to our template and also adopted many of the suggested TOC/heading changes from ICH guidelines. We have also cited it in the template as an aid for less experienced writers.

Jo MacKenzie
Senior medical Writer, Parexel

Please notify us if you or your organisation have adopted the use of CORE Reference. Is CORE Reference, for example:

  • Included in standard operating procedures (SOPs)
  • Included as a reference in departmental working procedure(s)
  • Circulated for review within organisation/department
  • Planned for further review for potential integration.