Doug Bain, Chief Technology Officer at KCR KCR was one of the first companies in Europe to use Veeva as a platform for our electronic Trial Master File (eTMF). Back in 2014, we took an adventurous step of digitalizing the flow of documents across our clinical trials. Eight years later…

Doug Bain, Chief Technology Officer at KCR For over 20 years, the clinical research industry has been seeking to phase out data transcription from paper or EHR systems into an EDC systems eCRFs. …

Karoline Hahn, Senior Consultant. Advanced Therapies, KCR Historically, cell and gene therapy medicinal products have been rare in the drug market. Meanwhile, ten cell and gene therapy products have been launched to the US market and thousands of advanced therapies are in the pipeline as of April 20221. Beyond doubt…

By Doug Bain, Chief Technology Officer at KCR As a consumer of software products that accelerate the execution of clinical trials, we frequently need to navigate the minefield of vendors able to meet varying demands that clinical research presents. KCR are an organically growing CRO that specialise in tackling clinical…

Doug Bain, Chief Technology Officer at KCR I had the great pleasure in speaking at the Veeva EU R&D and Quality Summit in Zurich 8th June 2022 together with Ruth Ruffieux from Alvotech and Mellisa De Swaef from Argenx. One of the challenges we face when running a clinical trial…

Dave Li, MD, PhD. KCR Principal Consultant The ASCO Annual Meeting was held from June 3–7, 2022, in Chicago. …

With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr. Dave Li and Dr. Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs. Introduction Over the past few decades, we have witnessed significant progress in…

Karoline Hahn, KCR While most medicines are derived from chemical compound, biologics are now the fastest-growing drug class. Over the past five years, eight out of the top ten best-selling drugs were biologics, with therapeutic antibodies at the forefront (DOI: 10.1186/s12929–019–0592-z). By February 2022, the Food and Drug Administration had…

One of the key tools in the effective implementation of a Decentralized Clinical Trial is the design of the Patient Journey. …