Clinical Development

Find providers for clinical development services. The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided.

If you are a provider of services in this area, you have the possibility to register free of charge in this directory.

Saidia Pharma Service Limited

Bei den Mühren 66a

20457 Hamburg

Germany

info@saidiapharma.de

Homepage 

  • Management of Post-marketing Studies (PASS and NIS)
  • IMPDs and Dossier compilation
  • Scientific Advice
  • Upload §42 AMG - clinical trials portal


analyze & realize GmbH

Waldseeweg 6

13467 Berlin

Germany

business@a-r.com

Homepage

 

  • Long-standing experience in designing, planning, implementation, evaluation and publication of clinical trials to obtain/extend the product approval or optimize product marketing
  • Studies for substantiation of Health Claims (according to current EFSA guidelines)
  • Non-interventional studies (NIS), observational studies
  • Core competences: Studies with herbal drugs, OTC / Rx drugs, dietary supplements, functional food / nutraceuticals, medicinal waters (drugs), substance-based medical devices, homeopathics
  • Own study site/investigational site in Berlin: Recruitment of healthy volunteers and at-risk patients, bioequivalence studies


Ramos Pharma Consulting

Schweidnitzer Str. 63

80997 Munich

Germany

yr@ramos-pharmaconsulting.de

Homepage

Advice and practical support regarding:

  • Project management and study management NIS and clinical studies
  • Planning, execution and evaluation of clinical studies (phase I-IV, late-phase), NIS and registries
  • From investigator selection and meetings to Study close-out
  • Preparation of documents relevant to the study and preparation of study submissions
  • Supervision of monitoring activities and CROs
  • Mentoring of Clinical Research Associates (CRAs)/Co-Monitoring
  • Clinical Trial Liason (CTL)


3R Pharma Consulting GmbH

Wildbader Str. 3

75335 Dobel

Germany

tobias.zahn@3rpc.com

Homepage

 

  • Strategic and scientific advice on the clinical development of pharmaceutical products meeting current and future regulatory requirements and standards
  • Review, quality control or generation of scientific and clinical study related data, reports and essential documents according to ICH Guideline E6(R2)
    - Investigator’s Brochure (IB)
    - Clinical study protocol
    - Clinical study report
    - Study oversight and risk management plan
  •           Generation of reports, summaries, expert statements, briefing books

  • Organisation of and attendance at meetings with regulatory agencies (e.g., scientific advice meetings, protocol assistance meetings)
  • Regulatory applications for
    - Orphan Drug Designation (EMA, FDA)
    - Paediatric Investigation Plan (EMA)
    - Pediatric Study Plan (FDA)
    - Clinical Trial Applications (CTA, IND)
    - SME status (EMA)


ELC-Group s.r.o

Karolinská 650/1,

186 00 Prague 

Czech Republic 

info@elc-group.com

Homepage

 

  • Strategic designing of Pre-clinical & Clinical development programs for drugs and devices including
    - Pre-clinical studies
    - Bioavailability/Bioequivalence (BA/BE) and Phase I studies
    - Phase II to Phase IV and PMS studies
  • medical writing
  • Biostatistics and Statistical Programming Services
  • Clinical Data Management (CDM)
  • GCP Audits and training


ERA Consulting GmbH 

Lange Strasse 70 

29664 Walsrode

Germany 

Tel: # 49 (0) 5161 9890 0 

Fax: # 49 (0) 5161 9890 18 

info@eraconsulting.com   

Homepage   

ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic.

 

  • CTA/IND compilation and submission
  • IMPD/IND authoring
  • Support for Scientific Advice
  • Communication with regulatory agencies
  • Applications for Orphan Drug Designation (EMA, FDA), Paediatric Investigation Plan (EMA), SME status (EMA)


Logo Pharmexon

Pharmexon Consulting s.r.o,

Krakovska 22 Prague 1

11000 Prague

Czechia

info@pharmexon.com

Homepage  

Pharmexon is able to advise on aspects of the development of a medicinal product or device at any stage of development. More notably, our clients would like “strategic inputs” even at target selection stage. This is important to note in order to understand the local and global pathway a development must follow. We are able to apply our experiences to identify possible pitfalls and common problem that can occur. Our experts are able to design preclinical and clinical strategies, synopsis and protocol. We provide appraisals of data/ideas as well as set-up and facilitate interaction with Agency committees.

Some of the services offered in this area are:

  • Clinical advice on “hybrid/505b2” developments of known APIs
  • Classification/advise on pathway for most medicinal product types
  • Regulatory/preclinical/clinical Strategy reports on new pharmaceutical forms/delivery systems/new administration routes/new dosages for purpose of business planning
  • Biosimilar advice for truncated programs according to current guidelines
  • Leveraging data from regional developments for global registration strategy and vise versa
  • Drug Device combinations
  • Advise on PK/BE strategy for standard and complex generics


PharmaLex GmbH

Harrlachweg 6

68163 Mannheim

Germany

Homepage 

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

 

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

 

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

  • Clinical development program strategy and design
  • Indication strategy and developments
  • Target product profile development
  • Clinical development strategy and plan, trial design, study endpoints accelerated approval
  • Program and study-level biostatistical-regulatory strategy
  • Regulatory landscape analysis and road map
  • Expedited/Adaptive Pathways and Orphan Drug Designation support