Outsourcing in Clinical Trials Nordics 2020

Medidata

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Medidata is leading the digital transformation of life science, with the world's most used platform for clinical development, commercial, and real-world data. Powered by artificial intelligence and delivered by top-ranked industry experts, Medidata helps pharmaceutical, biotech, medical device companies, and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata and its companies, Acorn AI and SHYFT, serve 1,300 customers and partners worldwide and empower more than 150,000 certified users every day to create hope for millions of patients. Discover the future of life science: www.medidata.com

Company Website: www.medidata.com

Worldwide Clinical Trials

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website: www.worldwide.com

LUMIS International

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Lumis International is a service organization head-quartered in Germany. We are specialized to support small to midsized biopharmaceutical and medical device companies in their outsourcing, vendor management and clinical trial oversight management. With our approach and our tools we help you to be inspection ready and to comply with regulatory requirements.

Company Website: http://www.lumisinternational.com/

SYNLAB

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: SYNLAB Pharma, a segment of the Business Unit SYNLAB Analytics & Services Germany GmbH of the SYNLAB Group, offers a very broad range of laboratory services to the biotechnology and pharmaceutical industries as well as to manufacturers of medical devices and novel foods. SYNLAB Pharma´s portfolio includes global clinical trial services, bioanalytical services, advanced biomarker testing, personalized medicine concepts, logistics, long-term sample storage, production monitoring incl. extractables & leachables, product release and stability studies. SYNLAB Pharma supports the complete drug development cycle from preclinical toxicology and PK projects through all clinical phases and beyond.. Our clients take advantage of our large spectrum of analytical methods for drug development and production control; always working in accordance with the highest standards such as DIN/EN ISO/IEC 17025/15189, GMP, GLP, GCLP or GCP. See us as your ONE-STOP-SHOP – and take advantage of our experience gained in more than 25 years and 3,500 clinical trials.

Company Website: www.synlab.de

4pharma

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: 4Pharma is a specialized CRO with unique niche competence in biostatistics and data management. Since 2002 the company provides services to pharmaceutical, biotechnology, medical device and food companies. With offices in Finland and south of Sweden, the company offers local Nordic expert collaboration both with the industry and clinical CROs.

Company Website: http://4pharma.com/

Cerba Research

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to improve the lives of patients around the world.

Company Website: www.barclab.com

DSG

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink™ EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services.

Company Website: http://www.dsg-us.com/

ESMS Global

Industry: Healthcare,Outsourcing Clinical Trials,

Company Website: www.esmsglobal.com

ICON

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

Company Website: http://www.iconplc.com/

IDDI

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology. IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials. - IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing. - IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology. - Experience: 27+ years - 980+ trials (630+ in oncology) - 20 FDA/EMA approvals to-date - HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

Company Website: http://www.iddi.com/

Intertrek

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Intertek’s GLP/GCP/GMP compliant laboratories provide support to clients focused on the development of pharmaceuticals and biologics helping through GLP/GCP Bioanalysis, GMP/CMC Laboratory Services, GMP Auditing and Regulatory/Toxicology Consulting. Our bioanalytical capabilities include method development, validation, method transfer, sample analysis and pharmacokinetic and toxicokinetic support. Our biomarker services provide both fit-for-purpose validations in support of exploratory biomarkers and full validation for biomarkers used as a companion diagnostic. An array of innovative platforms enable drug efficacy and safety profiling including ultra-sensitive ELISA, flow cytometry, cell-based assays and ECL multiplex platforms as well as provision of immunogenicity bioanalysis for pre-clinical and clinical studies.

Company Website: http://www.intertek.com/pharmaceutical/

KLIFO

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: KLIFO is a leading drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. At KLIFO, we offer multi-diciplinary consulting and operational solutions spanning all areas of regulatory affairs, clinical research, clinical trial supply, CMC development, regulatory affairs, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices.

Company Website: www.klifo.com

Larix

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Larix is a full service Clinical Research Organisation (CRO), offering assistance in all aspects of clinical trials, to pharmaceutical, biotechnology and medical device companies We have experience in phase I-IV trials in many therapeutic areas and have provided services to most major Danish pharmaceutical and medical device companies.

Company Website: https://www.larix.dk/

Unilabs

Industry: Healthcare,Outsourcing Clinical Trials,

Company Website: www.servingpharma.com

SQN

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: SQN Clinical is one of the largest specialist Biometrics CROs in Europe. Noted for our high quality, flexibility and personal approach we have been supporting global pharma, biotech, medical device and animal health partners with innovative, cost effective clinical development services for nearly 25 years.

Company Website: http://www.synequanon.com/