the CTL agency

the CTL agency is a cooperation between Birgitte Lassen Rossau (b. pharmaconsult ivs) and Karina Lippert (KaLiCo ApS). We met at Pfizer in 1999 and have been close friends and colleagues since then. Together we represent about 60 years of Clinical Research experience – from CRA positions to Director, Clinical Operations and Country Manager. We have worked within various therapeutic areas and have experience working in the Pharmaceutical Industry as well as in the CRO business. We share a great passion for Clinical Research. From 2014 to 2020, we successfully developed and implemented the Clinical Trial Liaison (CTL) role at Regeneron Pharmaceuticals and supported clinical development programs in all of Europe. At Regeneron Pharmaceuticals the CTL role has expanded to global presence on all outsourced therapeutic programs and is now part of a global FSP program. In an outsourced model, the CTL role closes the gap between sponsor and investigator sites. The CTL role is the local, field-based sponsor representative, focused exclusively on engaging sites participating in clinical trials. The CTL role may support: Feasibility – Site & Country Selection Pre-Study Visits (PSVs) Investigators’ Meetings & CRA trainings Site Initiation Visits (SIVs) Patient Recruitment & Retention Strategies Issue Management and Database locks Motivational, Booster & Sponsor Visits Audits & Inspections Further, the CTL role contributes to the sponsor oversight requirements according to GCP part 5.2.2. Metrics have documented the value of the CTL role, especially on patient recruitment. Further, lessons learned following database locks and stake holder feedback show that the CTL role is a unique role contributing to strong site relations and timely delivery of high quality clinical trial data. We develop and implement the Clinical Trial Liaison role, adding value to sponsors outsourcing clinical trials.