We are proud to annouce the availability of QCTMS RM and CROMS V1.10.0 as of 04-May-2019. This upgrade introduces various new features that make using our systems even more efficient and that enables us to tailor them to study-specific any further. May the Force be with you!
German BMBF has announced funding of clinical trials for patient-centric indications. Details can be found at https://www.bmbf.de/foerderungen/bekanntmachung-2365.html (German only) With PCQ Pilots’ software services you will benefit from tools that have been developed out of the daily clinical research business.
According to German DIMDI, DIMDI will provide its official medical classifications free of charge starting April 1st 2018. DIMDI announced to offer a downloading option for these classification files (ICD-10 etc.). DIMDI’s web shop will not be needed anymore. More can be found at http://www.dimdi.de/static/de/klassi/aktuelles/news_0435.html (German only).
German BMBF has announced additional funding of clinical trials. Details can be found at https://www.bmbf.de/foerderungen/bekanntmachung-1609.html (German only) With PCQ Pilots’ software services you will benefit from tools that have been developed out of the daily clinical research business.
Electronic Patient Reported Outcome (ePRO) often suffers from poor subject compliance and high costs. With QCTMS ePRO we offer you a ePRO that lets the subjects use their own devices, e.g. mobile phones, tablet computers, or laptops. QCTMS ePRO will therefore be part of the subject’s daily routine, but also […]
The new release of QCTMS TMF integrates an electronic Investigator Site File (eISF), which eases the process of distributing documents to the sites. It also greatly improves read&understood processes and lets monitors check ISF completeness remotely. If you would like to see your study benefit from an eISF, please don’t […]
ISO 9001 and ISO 13485 are wide-spread standards, especially among our clients. The current revisions have a strong focus on processes and how these processes are controlled. In addition, risk-based approaches are key priniciples. With QCTMS RM and CROMS you are gaining important insights into your processes, while also having […]
Andreas Grund and Jörg Mielebacher published an editorial on e-TMFs. It discusses the requirements and impact as well as the benefits for sponsor, CRO and auditors. You can find the editorial in Journal for Clinical Studies 7 (4). The fulltext is available here.
Meet us at the Clinical Operations and Outsourcing in Medical Devices Trials 2015 in Munich on 10th/11th Feb. Get in touch with our team to discover our solutions for MD companies.
EMA’s reflection paper on GCP compliance related to TMF describes how an electronic Trial Master File (eTMF) should be designed. With QCTMS TMF we offer such a solution. With QCTMS TMF your study team easily maintains a centralized electronic Trial Master File. Setup the TMF structure according to your SOPs, […]