BIOSCIENTIA. Good outcomes are based on good values. Central lab services and biomarker analytics for clinical trials

Transcription

1 BIOSCIENTIA Good outcomes are based on good values Central lab services and biomarker analytics for clinical trials

2 BIOSCIENTIA Do you remember when US President Ronald Reagan appealed to Michail Gorbatschow in Berlin to tear down the wall?... the first medication against HIV was approved by the FDA?... the world population hit the 5 billion mark? It was in In the same year, Bioscientia was one of the first European laboratories to obtain accreditation through the College of American Pathologists (CAP). Why are our 30 years of know-how as a laboratory in clinical research not just as present in your mind as the events mentioned above? Clinical trials have been one of Bioscientia s core competencies from the beginning. We have been involved in the laboratory medicine aspect of several hundred projects for pharmaceutical and biotechnology companies as well as CROs. Now, we ll make the good even better. As a part of the globally operating Sonic Group, we offer our partners benefits in terms of internationality, expertise and service. Get to know Bioscientia clinical trials lab and we will make a lasting impression on you.

3 We are by your side. If you want to be successful, you need excellent trial results. As an analytics specialist, we offer you the safest lab results possible. Your benefit for failure safety: Being a part of Bioscientia/Sonic Healthcare, the Ingelheim Central Laboratory for Clinical Trials operates within a worldwide leading network of laboratory sites, life science professionals, scientists and logistic service providers with defined backup systems. Your benefit for patient safety: In cases of emergency, our on-call duty is available to you around the clock.

4 Gain quality. Save time. Reduce cost. Safely. Bioscientia diagnostics for life Medical progress, new ways of healing, economic success clinical research makes an important contribution here. It all begins with diagnostics. How can we support you in reaching your goals? Quality Patient safety and validity are ensured by our special departments with experts from all fields of laboratory medicine, human genetics and microbiology. Classical safety analytics: Haematology, clinical chemistry, coagulation Biomarker analysis: Haematology, oncology Pharmacogenetics, tumour genetics Clinical chemistry Metabolic markers M i c r o b i o l o g y Molecular biology Toxicology, drug monitoring Infectious diseases Immunology, serology Endocrinology Clotting tests Veterinary medicine You get comprehensive solutions for your analytical issues from us. Our medical specialists and scientists are there for you also and especially when you have to react promptly to deviations of the trial participants vital functions. Time Our dedicated support of trial centres and clinical monitors enables the studies to run smoothly and efficiently. The Bioscientia Group provides flexibility and failure safety. One of our quality features is advanced sample logistics. Costs We achieve cost benefits for you by bundling all tools and services of the Bioscientia Group. Take profit, for example, from high sample throughput and logistics that work. From efficient and secure data management. From the expertise and experience of our project managers.

5 Your benefits at a glance Full-service support: Planning, consulting at the highest scientific level, exhibitions, data processing, data export, publications, individual trial kits, training courses for trial centres, clinical monitors, and much more. One face to the customer: Experienced project managers as personal contact partners for all phases of the cooperation. Pool of specialists: Specialty fields for all aspects of laboratory-based medical analytics, including human genetics, pharmacogenetics, drug monitoring, molecular biological analyses, cellular function tests, etc. Complete spectrum of tests and methods: More than 2,500 analysis parameters plus individually developed methods for clinical trials. Medical on-call duty 24/7/365 Logistics that work: Quick transport of samples nationwide and abroad Quality at the highest level: Accreditation and certification as per DIN EN ISO 15189, DIN EN ISO/IEC and forensics. Accreditation by the College of American Pathologists (CAP), CLIA certificate, participation in more than 900 round robin tests (e.g. CAP, INSTAND, RfB, NEQUAS). Decades of experience: Analytics and support for as many as several hundred trials of phases I to IV. Trial-specific IT solutions: Individual reporting and data export options, plausibility checks, data security, etc. Access to multinational groups of participants: Worldwide network of laboratories and university experts: Western / eastern Europe, Africa, Arab peninsula access to Asia, America and Australia through our Sonic Healthcare Network. Archiving of samples according to requirements: In-house storage under controlled conditions at 4 8 C, -20 C and -70 C continually monitored.

6 BIOSCIENTIA Talk to us Together with you, our project managers will draw up a diagnostics and analytics design for you. From trial setup to reporting. Whether safety parameters or special analytics. For monocentric to multi-national studies. From preclinical to phase IV. Throughout the trial progress, a person of trust is available for all your concerns. Good success in your trial! clinicaltrials@bioscientia.com Bioscientia Institute for Medical Diagnostics GmbH Clinical Trials Lab Konrad-Adenauer-Str Ingelheim Germany Phone: Fax: clinicaltrials@bioscientia.com DesignVoice GmbH