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We genuinely believe that being GLOBAL IN MIND AND LOCAL AT HEART is the core of our success; our customers know TFS' in-depth knowledge about regulatory and clinical trial requirements in every country, ensures a global trial will move faster to market and result in shorter timelines to get treatments to the patients who need them.
https://www.tfscro.com/contact-us
TFS International AB PO Box 165 SE-221 00 Lund Sweden. Visiting address: Medicon Village Scheeletorget 1, building 601, 4th floor SE-223 81 Lund Sweden
https://www.bloomberg.com/profile/company/4381097Z:SS
TFS Trial Form Support International AB operates as a clinical contract research organization. The Organization provides clinical development planning, regulatory affairs, medical informatics ...Founded: 02 Jun, 1995
https://www.cmocro.com/company/Trial+Form+Support/index.html
Trial Form Support is a full-service clinical Contract Research Organisation (CRO) dedicated exclusively to the clinical drug development process.
http://www.appliedclinicaltrialsonline.com/eu-trial-review-changes-reg-5362014-netherlands
Jan 22, 2015 · EU Trial Review Changes from Reg 536/2014: The Netherlands. Jan 22, 2015 ... the HRA is working on a pilot of the effects of offering clinical trial applicants early advice and support. Preliminary findings show that the number of provisional opinions (approvals based on additional conditions to be met by the applicant) being issued by RECs has ...
https://www.tfscro.com/about-us/our-history
In the mid-90s TFS’ services mainly included planning, development and design of clinical trial related documentation, hence the name “Trial Form Support”.
https://www.clinicalleader.com/doc/regulatory-approval-of-clinical-studies-in-the-netherlands-0001
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. Prior to beginning a clinical trial, an identical Clinical Trial Application (CTA) dossier has to be submitted in parallel to an accredited Ethics Committee and to the Centrale Commissie Mensgebonden Onderzoek (CCMO=Competent Authority).
https://neonatalresearch.org/2013/07/16/more-support-controversy/
Jul 16, 2013 · More SUPPORT controversy. ... Prior to enrollment in the SUPPORT trial there was a complete disclosure of the nature of the trial, and the fact that the two saturation ranges being compared were both within the normal standards of care, parents were informed of the masked nature of the intervention, and the fact that the purpose of the trial ...
http://alicedreger.com/support
The SUPPORT study was a large randomized control trial (RCT) that ran from 2004 to 2009 and was aimed at finding out how to improve treatment of babies born prematurely. Approximately 23 institutions participated in this NIH-funded trial of about 1300 preemies.
http://www.eurecnet.org/information/netherlands.html
The CCMO has a broad range of legal tasks (accrediting MREC’s, competent authority for clinical research with medicinal products, in specific cases reviewing protocols for medical research involving human subjects, registering all WMO research reviewed in the Netherlands, administrative body for appeals and objections and providing ...
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