Cro capabilities list june 2017

UK Clinical Research Organization Capabilities List

BIO Convention, May 2017

San Diego, CA

To connect with any of the companies listed here, please contact

Torrey.ah-tye@mobile.trade.gov.uk Kathryne.kirk@mobile.trade.gov.uk

Contents

First in Human & Early Stage

3

Full Service CROs

4

EDC & Data Management

6

Clinical Trials Logistics

7

Clinical Trials Support

8

FIRST IN HUMAN & EARLY STAGE

2

Keywords: Innovative clinical trial design, Vaccines, Ophthalmology, Women’s Health, Respiratory Health, Diabetes, Medical Devices, Quality Assurance & Qualified Persons, Scientific Support

1

http://www.biokineticeurope.com/

2

http://www.biotrial.com/

3

http://www.hmrlondon.com/

4 http://www.quotientclinical.com/

Description: BioKinetic Europe is an independent, owner-managed Contract Research Organization in Belfast, UK. Keywords: Early clinical development, Translational Research, Oncology, Biometrics, Bioanalysis, SMO, SAE, QA Description: With state-of-the-art facilities, highly qualified staff and over twenty eight years of experience, Biotrial is a leading provider of Non-Clinical Pharmacology services, Phase I-II clinical services, Data Management, Statistics, Core lab d Bioanalytical services Keywords: Clinical pharmacology, phase 1, phase 2, first in man, Japanese & ethnic bridging, QT, pharmacodynamics, aseptic pharmacy, radiopharmacy Description: Hammersmith Medicines Research Limited is one of the largest early-phase units in Europe (145 beds) offering full service for phase 1 and early phase 2 studies, from design to report, and is MHRA accredited.

Keywords: Enabled-FIH, Pharmaceutical Spray Dry Description: We are a well-established drug development company focused on delivering truly innovative solutions to help our customers improve their R&D productivity.

Keywords: Adaptive, Thorough-QT, Japanese & Ethnic Bridging Studies, Patient Recruitment, Drug Free Plasma

5

http://www.richmondpharmacology.com/

St ud ha ie se s II Ph S tu ar d m ies ac y C ap Tr ab ial ilit & ie P s ro to co Da l ta D es St M a ig at n n ist ag Et ics em hi e nt c & Su s &

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ha se I

Size: Small/Medium

Region: Northern Ireland

Size: Medium

Region: London

Size: Large

Region: London

Size: Medium Region: Northeast

Size: Medium

Description: Richmond Pharmacology is a full-service specialist clinical research organisation (CRO).

Region: London

Keywords: Oncology, rare & orphan diseases, respiratory, dermatology and infectious vaccines & diseases, QA, IMP

Size: Large

6 http://www.simbecorioncro.com/simbec/

Ea rly P

tu di es Ph as e

I S

About

Ad ap tiv

Company

Description: Simbec Research is a full-service MHRA accredited facility able to carry out all types of studies, including First-in-Human studies.

Region: Wales

3

About

Ph as e

Company

I- I V Ph ar m ac ov igi Gl lan ob ce al S Fe er as vi ib ce Bi ilit s os y S ta tu tis di tic es s Tr ial & P ro to co Da l D ta M es ig an n ag em Et hi e nt cs & & R S ta eg ts u M la ed to ica ry S l W ub rit m Pa it in g ti e & nt A R f f air ec ru s Ph i tm ar en m ac t y C ap ab ilit ie s

FULL SERVICE CROs

1

https://www.chiltern.com/

2

http://www.cmedresearch.com/

3 http://www.ergomedplc.com/

4 http://illingworthresearch.com/

5

Keywords: Oncology, Neurology, Respiratory, Cardiovascular, Endocrinology, Infectious Diseases, Vaccines, Ophthalmology, Dermatology Description: A global CRO, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services to the biopharmaceutical and medical device industries.

Keywords: Complex Studies, Oncology, Rare Diseases, Small Biopharma, Large Pharma, Clinical Operations & Monitoring, eClinical Technology, Clinical Data Suite, eSource, EDC, Consulting, Full Service, FSP Description: An innovative, full service technology-led CRO, bringing together experienced people and our own innovative eClinical technology to successfully deliver clinical trials. encapsia™, Cmed’s new generation clinical data suite, streamlines the capture, management and reporting of clinical trial data.

Keywords: Oncology, Neurology, Immunology, Rare Diseases Description: UK headquartered global mid sized CRO with fifteen offices and five hundred people, providing full service clinical and pharmacovigilance services. In addition, the company operates a shared risk division and develops its own products in the surgical bleeding area.

Keywords: Respiratory, Orphan Indications, Dermatology, Oncology, Infertility, Early Phase, Cardiology Description: We are a contract research organization (CRO) specialising in Phase I to IV clinical trials and in the provision of mobile clinical research nurses and medical photography.

Size: Large Region: Southeast

Size: Medium

Region: Southeast England

Size: Medium Region: Southwest

Size: Large Region: Wales

Keywords: Respiratory, inflammatory medicine, Asthma, COPD, Rhinitis, Cystic Fibrosis

Size: Large

Description: The Medicines Evaluation Unit (MEU) Ltd, is one of the UK’s leading contract research organizations,

Region: Northwest

http://www.meu.org.uk/capabilities.asp

Keywords: Experts in Infection. Antibiotics, Vaccines, Monoclonal Antibodies, Oncology. Antibiotic Resistance Surveillance 6 http://micron-group.com/

Description: The Micron Group is an international clinical research organization, specializing in anti-infectives and oncology. We provide full and comprehensive support for the development and lifecycle of Client

Size: Medium Region: Cambridgeshire

4

http://nweh.co.uk/

Keywords: EHR-Enabled RCTs, pRCT, Real-time Safety Monitoring, Realworld, NHS Trusted Partner, Feasibility & Recruitment, Protocol and Trial Design, Healthcare Resource Utilization, Long-term Follow-up Description: NWEH’s technology enables more effective feasibility, economic modelling, recruitment, real-time safety monitoring and data analytics to support the whole clinical trial lifecycle. We are the only organisation in the world to have evaluated the safety and effectiveness of a pre-license medicine in a real-world setting.

I- I V Ph ar m ac ov igi Gl lan ob ce al S Fe er as vi i ce bi Bi s l ity os ta S tu tis di tic es s Tr ial & P ro to co Da l D ta M es ig an n ag e Et m hi en cs t & & R S ta eg ts u M la ed to ica ry S l W ub rit m Pa it in g ti e & nt A R ffa ec irs ru Ph i tm ar en m ac t y C ap ab ilit ie s

About

Ph as e

Company

7

Keywords: Cardiovascular & Metabolic diseases, Central Nervous System, Dermatology, Infectious Diseases, Ophthalmology, Oncology, Vaccines Description: O4 Research is a dynamic and innovative CRO, operating throughout the UK, Ireland and with partners Europe-wide. Our focus is on providing a personalised, high quality, cost effective service which extends across Phases II-IV, Real World, Non-Interventional and Investigator Initiated studies.

8

Size: Medium Region: Northwest

Size: Medium

Region: Northern Ireland

www.o4research.com

Keywords: Oncology & Hematology, Cardiovascular & Metabolic Diseases, Central Nervous System (CNS) Disorders, Infectious Disease 9

http://www.parexel.com/

10

http://www.pharmalys.com/

11

Description: PAREXEL International is a biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries.

Keywords: CNS, Pain Management, Parkinson Disease, infectious diseases Description: Pharmalys is a trusted Niche Contract Research Organisation (CRO) based in the UK and in Senegal. We cover mainly The UK, Ireland and West and Central Keywords: Gene and Cell therapy, Regenerative Med, Rare diseases, CNS, Dermatology, Endocrinology, Cardiovascular, Oncology, Nephrology, Respiratory, Gastroenterology, Rheumatology, QA services, Drugs and devices

Description: The Clinical Trial Company Limited operates as a clinical http://www.theclinicaltrialcompany.com/ contract research organization.

Size: Large

Region: Northern England

Size: Small Region: South England

Size: Medium Region: Scotland

FULL SERVICE CROs cont.

5

Company

About

He al th Ec on om Re i cs al ti O m ut e co Re m po Re es r al tin W g or ld P Da ha se ta C I V ap St tu ud r e D ies Tr ial el iv & er P y ro to co Da l D ta M es ig an n ag em Et hi e nt cs & & R S ta eg ts ul M a ed to ica ry Su l W bm rit Do it in g cu m en t M HT an A ag em en t

EDC & DATA MANAGEMENT

Keywords: Real-world research, Longitudinal Studies, Registry Studies Description: With deep expertise in real-world research, we are passionate about advancing technology for real-world studies.

1 http://www.cisiv.com/

2 https://www.datatrial.com/

3 http://micron-group.com/

4

http://nweh.co.uk/

5

Keywords: Compliant Document Management, Data Storage, Real Time Reporting complex studies Description: Datatrial are a technology-focused business with a mature and elegant EDC system. We also offer a compliant document management solution and data storage.

Keywords: Antibiotic Resistance Surveillance, Outcomes Research, Observational Studies, Electronic Data Capture Description: Data Management Company. 20 years experience in bespoke software for drug development data capture and analyses.

Keywords: EHR-Enabled RCTs, pRCT, Real-time Safety Monitoring, Realworld, NHS Trusted Partner, Feasibility & Recruitment, Protocol and Trial Design, Healthcare Resource Utilization, Long-term Follow-up Description: NWEH’s technology enables more effective feasibility, economic modelling, recruitment, real-time safety monitoring and data analytics to support the whole clinical trial lifecycle. We are the only organisation in the world to have evaluated the safety and effectiveness of a pre-license medicine in a real-world setting.

Keywords: Data Management, EDC/ePRO, Statistics, Medical Writing, Quality Assurance, Data Collection Description: SQN is a specialist Biometrics CRO supporting local and global clinical trials.

Size: Medium Region: London

Size: Small Region: North England

Size: Medium Region: Cambridgeshire

Size: Medium Region: Northwest

Size: Large Region: South England

http://www.synequanon.com/ Keywords: Oncology, Immunology, haematology Description: Theradex (Europe), Ltd. operates as a niche contract research organisation which offers full regulatory (EU wide plus Australia) and clinical trial management, clinical trials, monitoring services, data management, statistics, clinical development consulting and QA/auditing.

6

Size: Large

Region: South England

http://www.theradex.com/

6

Keywords: Supply chain solutions, Specialty Storage 1

Description: We help our customers build, transform and operate the most effective supply chains in the healthcare industry, enabling better patient access, greater value and compliance. Our philosophy is ‘pallet-tohttp://www.alloga-network.com/ patient'.

Keywords: API, Clinical Trial Supply

2 https://www.almacgroup.com/

3 http://www.clinigengroup.com/

4 http://www.synexus.com/

Description: The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services globally.

Keywords: Comparator, IMP, WIMP, Ancillary, Stand of care, Expanded Access, Consulting Description: We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials.

Keywords: Phases 2 -4, Cardiovascular, Musculoskeletal, Respiratory, CNS, Endocrinology & Metabolic studies.

Description: Synexus is the world’s leading global Site Management Organisation (SMO), with a network of 27 dedicated research sites, 65+ affiliate sites and 1,000+ employees.

Synexus has engaged, recruited and retained patients in dedicated research sites for 24 years and is recognised as the patient’s choice for clinical research.

a

na ha ge in m So en Sit t lu e tio M ns an ag em Bi en ob t an ki ng Cl in ica l T ria ls Pa Su ti e pp nt lie R s ec ru Ph i tm ar en m ac t y C ap ab ilit ie s

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About

Co ld C

Company

W ar eh ou sin g & Su pp D ist ly C rib ha ut in io Pa So n ck lu ag tio in ns g & Gl La ob be al l li C ng o

CLINICAL TRIALS LOGISTICS

Size: Large Region: UK Multiple

Size: Medium Region: Northern Ireland

Size: Medium Region: West Midlands

Size: Large

Region: UK Multiple

7

Keywords: API, Clinical Trial Supply 1 https://www.almacgroup.com/ 2 http://www.cambreg.co.uk/

3

Description: The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services globally.

Keywords: Regulatory Consultancy Description: Cambridge Regulatory Services is a full service regulatory affairs consultancy helping pharmaceutical companies get their medicines to market faster.

Keywords: Comparator, IMP, WIMP, Ancillary, Stand of care, Expanded Access, Consulting

http://www.clinigengroup.com/

Description: We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials.

http://iaocr.com/

Keywords: Workforce accredidations, Workforce quality, Qualified ststus certification Description: The accrediting organization for the international clinical research sector. IAOCR helps embed organizational business processes that improve workforce quality, productivity and efficiency through Workforce Quality Accreditation and Qualified Status Certification.

4

5 http://www.qrcc.co.uk/

Re gu

About

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Te Po ce st st in A g pp

ro va Re l M gu ain la to te ry na A nc Bi ffa e om ir s ar ke r D i sc GC ov P Au er y & di ts D

ev La b Se rv ic e s

Company

W or kf or ce Ed Cl uc in at ica io l T n ria l

Su Ph pp ar m ly ac ov igi QA lan an ce d

CLINICAL TRIALS SUPPORT

Size: Medium Region: Northern Ireland

Size: Medium Region: Cambridgeshire

Size: Medium Region: West Midlands

Size: Medium Region: International

Keywords: Regulatory, Quality, Clinical, Consultancy

Size: Small

Description: QRC Consultants is your easy stepping stone for clinical development in Europe. We are experts supporting regulatory compliance for clinical drug development.

Region: Cambridgeshire

8