Optimapharm, a leading European, mid-sized, full-service Clinical Research Organization that provides successful tailor-made clinical research solutions to Biotech, Pharma and Medical Device companies, is delighted to announce the acquisitions of SSS and Crown CRO, significantly strengthening its presence in key European markets in Western and Northern Europe and expanding its in-house capabilities, for the benefit of its biopharmaceutical clients worldwide.

In the 2021 May issue of the renowned magazine International Clinical Trials, SSS reported about its experience in and knowledge of Phase IV trials. In this article, our authors focused on Post-Authorisation Safety Studies and their specific challenges when guiding and supporting sites in obtaining high quality data and in keeping timelines. SSS gained experience in this field from several studies and just recently implemented an IT solution for communication logs of the medical scientific expert team of the sponsor. By this means, SSS has facilitated the joint support from both, the CRO and the sponsor.

The increasing regulatory demands and the globalization of research has made clinical projects more and more demanding in recent years. In nowadays CROs have to handle much more information and interfaces. Starting already 15 years back SSS has developed a company-own Clinical Trial Management System (CTMS) system. Grown to a powerful tool it meets all requirements off full-service clinical projects in a global setting. SSS currently performs projects in 22 countries on three continents. In a recent publication in European Pharmaceutical Contractor from August 2020 we describe how such an integrated system enables mid- size CROs to perform even huge global projects.

The article "Datenflut in klinischen Studien beherrschen" published in the March issue of Pharmind by SSS gives an overview how to handle the increasing amount of data in clinical studies with Clinical Trial Management Systems (CTMS). Within the article we describe how low-code programming could help to create an own CTMS with moderate resources. High flexibility allows to align the system with processes of the company, to add new applications or to adapt to individual needs of client projects. SSS has followed this route and reports about their experience.

Over the past years pharmaceutical companies had to face unpredictable and increasingly long response times for clinical trial approvals in Romania. Now, the NAMMD published very encouraging figures showing a significant increase in clinical trial approvals in 2019 thanks to an ongoing restructuring process that NAMMD started in 2018.

From 01. April 2019 on the recommendations for the assessment of the investigator’s qualifications in clinical studies published by the `Arbeitskreis Ethikkommissionen´ has been replaced by a new version which has been passed by the Bundesärztekammer on 13./14. December 2018. The new recommendation comes along with some important changes, especially clinical expertise is more recognized now. In the future

On this year's TÜV SÜD medical device forum taking place in Hamburg´s historic "Kaffeebörse" SSS were invited to share their view in a presentation about the conduct of clinical investigations under the new medical device regulation (MDR). Dr. Max Mösmang, Senior Project Manager at SSS International Clinical Research, pointed out that the regulation which will come into force on 26. May 2020 will demand increased clinical evidence about safety and benefits to be demonstrated by manufacturers of medical devices.

The medium-sized contract research institute SSS Clinical Research celebrates its 25th anniversary. SSS benefits greatly from its IT-driven approach and is therefore well prepared for the digital future of the industry. Germering near Munich, 14.06.2018. SSS International Clinical Research GmbH (SSS), contract research institute for clinical studies (CRO), celebrated its 25th anniversary at Schloss Dachau. Initially started as an auditing service for the quality assurance of clinical research, the company has now established itself as a competent partner for international study projects for pharmaceuticals, biotech and medical technology companies.

This years "Deutschen Biotechnologietage" have been taken place for the eighth time. More than 900 participants from start-ups, universities, companies, funding bodies and public institutions met on the 18th and 19th of April in Berlin to discuss newest trends in the field. Highlight of this year’s event have been an address of the new German Mister of Economics, Peter Altmaier.

As early as 2010, the EU Regulation No. 1235/2010 kicked off a reorientation in drug safety. The aim was and is to create more transparency with standardized approval procedures and to provide faster and better information about drug safety. This November, the transitional period for the new version of the pan-European database ends.

From July 2017, Dr. Lars Behrend (45) will fill the role of COO, covering the key areas of financial management, controlling and business development. Lars Behrend holds a diploma in biology and a PhD in cancer research. He has 15 years work experience in management and consulting within the medical sector, biotechnology and cleantech areas.