SUPPLIERS’ DIRECTORY
Clinical Services International (CSI)
csint.com Clinical Services International
(CSI) is a global leader of sourcing and management of comparators for clinical trials. Headquartered in London and with operations in the UK, Germany, Japan and USA, it provides efficient solutions and serves worldwide trials. Its longstanding experience and relationships with manufacturers enable it to provide custom-made solutions to address the most complex requirements. It accelerates drug development and reduces timelines by providing a fully integrated service. Dr Vanessa Dekou, managing director E:
info@csint.com
N-SIDE N-SIDE, an innovative software consulting company, has been an active player in clinical trial supply chain management for more than 20 years. Using cloud- based, cutting-edge technologies, the N-SIDE Suite optimises the entire clinical trial supply chain management process from production planning to protocol design and delivery of supplies to patients. Amaury Jeandrain, senior director
IVR Clinical Concepts (IVRCC)
ivrcc.com
IVR Clinical Concepts implements cost- effective, secure interactive voice/web/mobile/native- app response applications (IVR/IWR/IMR/IxRS, IRT, RTSM, ePRO/eCOA) for patient screening/registration/ randomisation, trial supply management, and collection of eClinical Outcome Assessments, interfacing real-time data seamlessly between other eClinical technologies as needed. IVRCC provides time-sensitive notifications/ reporting tools to enhance compliance and streamlined management of clinical studies. Nancy Hudak, business development analyst E:
nancy@ivrcc.com/
busdev@ivrcc.com
S-CLINICA S-CLINICA offers ClinVision, a single platform for clinical supply forecasting, cost and risk optimisation, IWRS/IVRS, clinical supply management, drug return and destruction and ePRO. ClinVision ensures accurate planning of supply production and distribution and helps reduce supply costs and risks. S-CLINICA ensures and expedites fully flexible IRT support. Its drug supply management algorithm is unique in the market. Irena Seredina, executive director
TSafe
Lumis Life Science Consulting GmbH
lumisconsult.com Regulatory support, quality management as a service, outsourcing and oversight of clinical trials Lumis Life Science Consulting GmbH supports small and mid-sized medical device and biopharmaceutical companies in outsourcing their clinical activities. Our services cover CRO selection and management, clinical trial oversight management and training, as well as regulatory activities like obtaining scientific advice and applying for orphan drug designation. We analyse and establish complete quality management systems to ensure inspection readiness. Jointly with our customers, we develop tailored solutions to optimise their clinical product development. We collaborate with a network of experienced subject matter experts, cooperation partners and consultants to guarantee high quality in each of our service areas. Dr Christiane Juhls, project director
tsafelogistics.com TSafe acknowledges that your products are highly sensitive to temperature and need strictly controlled shipping solu- tions. TSafe’s precise planning, careful risk assessment and rigorous performance ensures a high-quality supply chain of API and an effective, IT-powered (iDEX) clinical trial distribution of IMP. This is key for a successful partnership with its customers. Patrick Rivera, general manager/Denis Look, CEO E:
info@tsafelogistics.com
Trilogy Writing & Consulting
trilogywriting.com Trilogy is a medical writing consultancy focused specifically on regulatory documentation. Medical writing is our pas- sion. We provide a service that is more than just writing – we proactively plan, coordinate and write regulatory documents to meet timelines, with a readability that reduces the time for review and approval. For more than 20 years, we have been helping pharmaceutical and biotech companies of all sizes, worldwide, to streamline their documentation processes and make sure their documents communicate clearly and effectively. Evija Kuemmel, head of corporate communications
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