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Life Sciences Report 2017 / 2018

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58 Life

58 Life Sciences Report – Contract Research Organisations Klinische Forschung Gruppe Nord GmbH The Klinische Forschung Gruppe Nord (Clinical Research Group North) is a network of independent investigator institutes with five centres in Northern Germany, two of them in Berlin.The Klinische Forschung Gruppe Nord has carried out trials with up to 250 patients. Phase II and III studies are the core competence. The test centres have altogether 30 overnight accommodation places for phase I and IIa studies. Lampe&Company GmbH & Co. KG Lampe & Company is a consulting firm specialized in multidimensional analysis of biomedical literature for evidence-based decision making. Our team of experts combines industry expertise with our unique L-Matrix Method and exclusive L&C relational database to deliver critical information to leading decision makers of pharmaceutical, life sciences, and medtech companies. LINK Medical GmbH LINK Medical is a full-service contract research organization (CRO). We provide services for clinical trials, regulatory affairs, pharmacovigilance, health economics and quality assurance for the pharmaceutical and medical device industry and aim for accelerating our customers’ product development. LUMIS International GmbH Based in Berlin, LUMIS International is specialized to provide support for small to medium sized biopharmaceutical sponsors to plan, implement and perform their clinical trials. Depending on our client needs we help to define the best outsourcing strategy, to select the service providers and to implement an efficient clinical oversight management system. LUMIS acts on behalf of non European Biopharmaceutical sponsors as their legal representation for clinical trials. The team at LUMIS and our consulting affiliates cover a brought range of experience in different indications as well as international operational experience working in CROs and biopharmaceutical companies. MEDIACC GmbH MEDIACC is the private, independent institute for Medico-Academic Consulting. We provide made-to-measure services based on more than 20 years of clinical and research experience to develop products for patients’ needs. The full service comprises potential assessment, development of a realisation concept to realisation of pre-clinical to clinical studies as IIT or following AMG and MPG. Our active support extends to concept and writing of publications for international specialist congresses or high-ranking peer reviewed journals. Highest quality comes from solid academic backgrounds, close link to centres of excellence and our strong network building interdisciplinary teams. We operate internationally based in Germany. Medis Research Group MEDIS RESEARCH GROUP is a partnership of clinical research services providers with a joint mission to combine clinical research expertise and provide complete service solutions across all stages of the clinical development process. OSMUNDA Medical Technology Service GmbH OSMUNDA Group is the leading clinical trial CRO and service provider of medical devices and pharmaceuticals. OSMUNDA is ready to assist with a comprehensive service chain and one-stop solutions in the technical, clinical and regulatory aspects of medical device industry, including clinical trials, global product registration and approval, biomedical data management and analysis, consultation and training. PAREXEL International GmbH The German subsidiary of the US clinical research organization PAREXEL employs more than 1,400 people in Berlin. In two units with a 160-bed capacity (incl. 8 sleep lab beds) and an annual enrollment of approximately 2,500 volunteers in Berlin, more than 75 clinical studies are performed each year. PharmaLex GmbH PharmaLex is one of the leading service providers in the International pharmaceutical business. The company is dedicated to the development, registration and marketing authorization, market access and product maintenance of medicinal / biotechnological products and medical devices, worldwide. The corner stones of PharmaLex’ successful co-operation with companies of all sizes and specializations are very high quality of work, reliability, efficacy, flexibility and anticipatory strategic planning. QiP GmbH The QiP - Quality in Progress - GmbH is a consulting enterprise, providing excellence services in a wide range of quality related themes. Our expertise is dedicated to the success oriented support of our clients, among them medical devices manufacturer, pharma and biotechnology companies, in various fields of activities: Life science, health, food and more. Our team qualifications include medical physics, clinical trials management, biotechnology and bioinformatics. We develop quality management systems, conduct audits and represent our clients in front of audits and inspections, compile clinical evaluations, and support e. g. the validation, risk management, and market authorisation processes.

Life Sciences Report – Biotech Companies 59 Sacura GmbH Sacura is a full-service contract research organization granting a high level of quality (FDA approved), flexible structures and qualified staff. syneed medidata GmbH syneed medidata GmbH is an independent, privately owned, contract research organization (CRO) that has been providing end-to-end services for phase II to phase IV clinical trials and for observational studies for more than 25 years. Since 1995, we have also excelled in trials involving medical imaging (oncology, neurology, radiology) and in trials with medical devices. WITEGA Laboratorien Berlin-Adlershof GmbH WITEGA Laboratorien Berlin-Adlershof GmbH is a medium-sized company specializing in the realization of organic customer syntheses. Our customers are companies from the chemical and pharmaceutical industries as well as from other technology fields. The main focus of our activities is the lab-scale custom synthesis of organic building blocks, intermediates and target structures and of isotope-labeled compounds (D, 13C, 15N) for chemical and pharmaceutical research and development. The company is also a supplier of analytical standards for residue analysis (especially in veterinary medicine). Biotech Companies 3B Pharmaceuticals GmbH 3B Pharmaceuticals GmbH (3BP) is a privately held pharmaceutical R&D company based in Berlin, Germany. The company is dedicated to the development of peptide-based pharmaceutical and diagnostic products. 3BP is pursuing projects in hemophilia and nuclear medicine. 8sens.biognostic GmbH 8sens.biognostic develops, produces and sells rapid tests (lateral-flow) and ELISAs for different markets (human and veterinary diagnostics, food control). Our products are the QuickSens ® -tests for h-FABP, TropI, CRP and hs-CRP and the Reader for quantification QuickSens ® OMEGA. Development-on-demand, feasibility studies and production-on-demand are also offered. ABiTEP GmbH The ABiTEP GmbH is working in development and production of biotechnological products for sustainable agriculture. The team of ABiTEP works for development of non GMO customer specific technologies in laboratory scale and scale up with modern equipment and Know how. Capacities for fermentation up to 5.000 L, down stream equipment as well as freeze drier with capacity of 90 L are available for services. A molecular biology lab is available for basic science. Accelero Bioanalytics GmbH Accelero ® Bioanalytics GmbH is a biotech CRO focussing on GxP compliant bioanalytical ligand binding assays. The company supports PK and PD preclinical/clinical drug development on microRNA, miRNA, siRNA, aptamers, plasmid APIs, antisense drugs, as well as peptide hormones, biosimilars, antibody therapeutics, or cell-based therapeutics (ATMP). The Applied Biosystems Viia7 real-time qPCR system with IVD label for human Dx operates in full compliance to Good Laboratory Practice (GLP). Acuros GMBH Development of osmotic micropumps for medical or microfluidic applications. The innovative technology enables new options in liquid handling – from disposable micropumps for drug delivery to precision micropumps for lab-on-a-chip development. Adrenomed AG Adrenomed AG is a privately financed, clinical stage biopharmaceutical company focusing on endothelial dysfunction and impaired vascular integrity. We develop safe first-in-class therapies for the treatment and prevention of impaired vascular integrity, which is one underlying pathophysiology of a variety of critical care conditions like septic shock and acute congestive heart failure. Lead candidate Adrecizumab is a humanized monoclonal Adrenomedullin-specific antibody, currently investigated in a Phase-II study in patients with early septic shock stratified for the bioactive target expression by a proprietary IVD assay. AFOSA GmbH Development, production and marketing of diagnostics (ELISA kits), primarily for use in veterinary medicine. Aglycon Mycoton GmbH Aglycon Mycoton GmbH is active in the research, development and application of biopolymers as well and their manufacture and the sales and marketing of products based on these.

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