Berlin – 20 April 2017 – Ensuring service delivery excellence has been a key element of development at KCR. By forming a new department for Clinical Trial Documentation Services (CTDS) the contract research organization (CRO) has further been focusing on effective document management and operational quality, including metrics driven compliance with document timelines.
“Clinical Trial Documentation Services has been established as a separate department at KCR with the unambiguous remit to focus on clinical trial documentation,” said Joette Keen, Head of CTDS. “From the set-up of the Trial Master File (TMF) in the state of the art Veeva Vault system to the ongoing oversight of timely document delivery, the CTDS team will be responsible for ensuring the constant availability of essential documents."
Along with the clinical trial data, the delivery of documentation, as evidence of the compliant execution of a study, is of paramount importance. “KCR’s commitment to ensuring the success of our customers by delivering a quality product and service at all times drives our organizational structure – including this most recent change,” added Ms. Keen.
The new department will be attentive to clients’ ongoing need to access and review documentation as part of clinical trial execution activities. To make this compliance visible KCR’s CTDS activities and oversight of documentation will be metrics driven and provide visibility on the current state of a study’s TMF on a regular basis.
“The company’s organizational structure will be aligned with the current Trial Execution Services (TES) model,” explained KCR CEO, Mike Jagielski. “CTDS is designated as an integral part of our full service delivery capability, however it also provides the option to be a stand-alone service to our clients. This is not a revolutionary change, but a clear commitment to operational excellence in the area of TMF management. We are positive that this change will be recognized by our clients as another step towards assuring their full satisfaction with our services,” he concluded.
If you would like to learn more about KCR Clinical Trial Documentation Services and/or KCR full services delivery, please contact Joanna Lewandowska, PR & Marketing, at firstname.lastname@example.org. Please include your full contact details in the query.
KCR is a Contract Research Organization (CRO) providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. More than 300 professionals support clients with full-service capabilities across our three main service areas: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP). Focusing on knowledge, quality and innovation, KCR offers reliable, customized and fast solutions to fulfill the clients' needs. The company’s geographical set up suits perfectly to deliver optimized trial execution strategies. Headquartered in Berlin, Germany, KCR operates across 20 countries in Europe, Asia as well as the U.S. This year the company celebrates its 20th anniversary.
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