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

ACM Global Laboratories

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website: www.ACMGlobalLab.com

ERT

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: ERT is a global data and technology company that minimizes risk in clinical trials, helping sponsors bring treatments to patients quickly, with confidence. ERT’s solutions have supported half of FDA new product approvals since 2013 by enhancing trial oversight, enabling site optimization, increasing patient engagement, and measuring treatment efficacy while ensuring patient safety.

Company Website: http://www.ert.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

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/

4G Clinical

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: 4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

Company Website: http://www.4gclinical.com/

Almac

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website: www.almacgroup.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

Covance

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description:

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives. www.covance.com.

Company Website: http://www.covance.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/

Endpoint

Industry: Healthcare,Outsourcing Clinical Trials,

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

ESMS Global

Industry: Healthcare,Outsourcing Clinical Trials,

Company Website: www.esmsglobal.com

Eurofins Biopharma Services

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Eurofins BioPharma Services provides seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. Our integrated solutions deliver the most comprehensive range of state-of-the-art analytical technologies with an expansive geographic reach in order to globally support our clients' clinical testing needs.

Company Website: http://www.eurofins.com/biopharma-services/

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/

Link Medical

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: LINK Medical is a full-service contract research organisation (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in the Nordics, UK, and Germany. Reaching from early phase development to post-marketing, we provide expert guidance across every aspect of a project – all from ONE source. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that support the delivery of superior clinical outcomes.

Company Website: http://linkmedical.no/

Oriola

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description:

With its expert services, Oriola provides pharmaceutical companies an effective access to Nordic markets. We improve consumers' wellbeing by ensuring that pharmaceuticals, health products and services are delivered in a safe and customer-friendly manner. Driven by our purpose, Health for life, we enable healthier tomorrow.

Company Website: www.oriola.com

QPS

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

Company Website: www.qps.com

SGS

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling & simulation and regulatory & medical affairs services. SGS has its own clinical unit in Belgium including a viral challenge testing facility and two phase I patients units based in Belgium and Hungary. SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in Infectious Diseases, Vaccines, and Respiratory.

Company Website: http://www.sgs.com/en/life-sciences/clinical-research-services

Signant Health

Industry: Healthcare,Outsourcing Clinical Trials,

Company Description: Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

Company Website: www.signanthealth

TFS

Industry: Healthcare,Outsourcing Clinical Trials,

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

Topa Thermal

Industry: Healthcare,Outsourcing Clinical Trials,

Company Website: www.topathermal.com

Xerimis

Industry: Healthcare,Outsourcing Clinical Trials,

Company Website: www.xerimis.com

YPrime

Industry: Healthcare,Outsourcing Clinical Trials,

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