About Translations & Licensing Management

The eCOA Translations and Licensing Management (TLM) project was conceived to try and address the persistent and high-impact challenges experienced by all stakeholders involved in the implementation of electronic clinical outcome assessment systems in clinical trials. There has been a broad and clear impact arising from the diverse approaches, processes, timescales and technologies involved in acquiring licences for COA measures and their translations, so Critical Path Institute (C-Path)’s eCOA Consortium and PCE Consortium came together to collaborate on developing a range of resources to help navigate the more prevalent points of friction. Seeing the key gap in the stakeholder group – the lack of representation of COA measure copyright holders/developers – C-Path forged an alliance with ISOQOL’s Translations and Cultural Adapation (TCA) Special Interest Group (SIG)*, and the content of this microsite serves as the platform for sharing those resources for public use.

The work is not yet done. More relevant resources will be added over time, not least those arising from our parallel collaborative initiative, the Clinical Outcome Assessment (COA) Measure Owners Forum (MOF). Additional suggestions for other resoucres can be made to eCOAC@C-Path.org.


Acknowledgments

The success of the TLM project was built squarely on the diligence and persistence of the project leadership: Teresa Willliams, Piero Bindi, and Kate Zarzar. In addition, the leaders of the various sub-teams deserve earnest congratulations:

Member Firms

  • Abbvie
  • AstraZeneca
  • Bristol Myers Squibb
  • Eli Lilly and Company
  • EORTC
  • FACITtrans
  • Fortrea
  • GSK
  • Health Psychology Research Ltd
  • ICON
  • Inspired Outcomes
  • IQVIA
  • Jassen R&D
  • Kayentis
  • MAPI Research Trust
  • National Institute of Pharmaceutical Education and Research (NIPER)
  • Novartis
  • Oxford University Innovation
  • Roche Products Ltd
  • RWS Life Sciences
  • Signant
  • Suvoda
  • Takeda Pharmaceuticals
  • TransPerfect
  • UCB
  • uMotif
  • Vitaccess
  • WCG Clinical Endpoint Solutions
  • YPrime

Contributors

  • Caroline Anfray*
  • Benjamin Arnold
  • Maria Arnott
  • Grazia Balestrieri
  • Dipika Bansal
  • Elinor Bethan-Rees
  • Anita Bradley-Gilbride
  • Barbara Brandt
  • Amber Bush
  • Anna Chilongo
  • David Churchman
  • Alexandra Crane
  • Karrie Crocco
  • Denise D’Alessio*
  • Kayla Doyle
  • Sonya Eremenco
  • Anne Evans
  • Valentina Gagliano
  • Guillaume Gantard
  • Lindsay Hedderly
  • Alisa Heinzman
  • Stacey Higgins*
  • Sonja Hooper
  • Marina Kec*
  • Simone Kina
  • Christian Knaus
  • Marlene Knupfer
  • Vanitha Krishna*
  • Dagmara Kulis*
  • Jeremy Lambert
  • Diane Leek
  • Glenda Leung
  • Elsa Lindstrom*
  • Helen Lundblad
  • Shawn McKown*
  • Flo Mowlem
  • Andrea Murison
  • Emily Parks-Vernizzi*
  • Ana Popielnicki
  • Emily Potz
  • Justin Raymer
  • Anna Richards
  • Foteini Sakellaropoulou
  • Hayley Simpson-Finch
  • Louise Simpson-Jones
  • Aman Thukal
  • Megan Turner
  • Mark Wade
  • Jasmine Walker
  • Martina Zagaria

*Note:  ISOQOL elected not to be recognized on an organzational level on the outputs hosted on the website, but all individual contributions from TCA-SIG colleagues have been recognised.