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. …

BOSTON, Mass — KCR, the international clinical development solutions provider, has announced the establishment of a new office location in Guildford, Surrey UK. The new location will enhance KCR’s regional coverage and maximize availability to research partners in the region. KCR CEO, Mike Jagielski, commented, “The establishment of a KCR…

Doug Bain, Chief Technology Officer at KCR The Ugly Patient is handed a tablet with a request to read and consent to participating in the trial as per the discussion they have just had with the investigator. On it, they see a document with lots of words that they can scroll through…

Karoline Hahn, KCR Senior Consultant for Advanced Therapies Gene editing as a tool for new therapeutics is entering the drug development space at a fast pace. The US Food and Drug Administration (FDA) had acknowledged this technological progress by releasing the draft guidance document, “Human Gene Therapy Products Incorporating Human…