Unified delivery of a broad range of services by a CRO within a single clinical trial can be difficult to do as each role within a CRO—be it a Clinical, Data or Laboratory Project Manager, is primarily focused on delivery of their own aspects of the trial.
However, with some considered planning, clever use of technology and a careful approach to communication, CRO teams can truly collaborate and deliver significant benefits to sponsors and sites, including:
An improved experience for the customer as a result of working with a single team.
Sponsor input is minimized on key documents as the unified team works together to define specifications and timelines, as well as critical site documents.
Study risks are minimized with a combined ICH GCP approved approach to risk assessment and mitigation.
Better site engagement through a series of tools and procedures that support sites and enable sites to perform.
A single site portal platform enables sites to conduct more activities online, reduce errors and reduce data queries.
A combined team approach to site training (and retraining where necessary) improves site compliance and achieves better quality data.
Earlier access to integrated, cleaner study data, resulting from an integrated laboratory and clinical data management process.
Integration of lab data into specific EDC platforms allows for rapid reconciliation and further downstream data analysis.
Ongoing cleaning of integrated data enables achievement of a prompt database lock.
Guest Contributor Michelle Lynskey is Director of Strategic Projects at ICON plc, within Laboratory Services. Lynskey has over 15 years of CRO and pharmaceutical industry experience. Since joining ICON in 2002 she has held a range of roles across Business Development, Clinical Laboratory Project Management, Client Services and Strategic Project Management. Lynskey holds a Bachelor of Science degree in Biotechnology from the National University of Ireland, Galway, a Bachelor of Science degree in Technology Management from the Institute of Technology Tallaght, Dublin and a Masters in Science Communication jointly conferred by Dublin City University and Queen’s University, Belfast. She is also PMP® and Lean Six Sigma Black Belt certified.
This article was reprinted from Volume 24, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
