About Us

Blueclinical R&D’s mission is to partner with institutions and companies in the development of successful translational medicine projects.

Blueclinical R&D has a unique expertise and experience in translational medicine and drug development. Our experience includes:

  • Preparing and implementing preclinical, clinical and regulatory plans for new medicines, medical devices and other health products.
  • Preparing and supporting the process of obtaining scientific and regulatory advice from competent regulatory authorities.
  • Placing and monitoring preclinical studies.
  • Preparing the investigator’s brochure and investigational medicinal product dossier (IMPD).
  • Preparing and submitting the clinical trial application to the competent authorities and ethics authorities.
  • Planning, conducting and reporting clinical pharmacology clinical trials (Phase I) in healthy subjects or patients.
  • Planning, implementing, monitoring and reporting therapeutic clinical trials (Phase II to IV) or observational studies with medicines or medical devices.

Preclinical and regulatory consultancy

Blueclinical supports sponsors in the definition of the target product profile and the definition of preclinical and regulatory plans.

Clinical trials full services

A Blueclinical R&D is prepared to provide qualified “full services”:

  • Organization of scientific and regulatory advice by pertinent regulatory authorities (FDA, EMA, etc.), when needed.
  • Clinical conduct in according with the best ethical standards and good clinical practice.
  • Data management and study reporting according to the latest regulatory requirements
  • Standard software used for the analyses (SAS, etc.).
  • SAS datasets organized in accordance with CDISC specifications for the FDA.
  • Established partnership with worldwide known GLP-accredited bioanalytical providers.

When clinical trials require multinational participation, the partnership between Blueclinical Ltd and SCOPE International AG allows expedite patient recruitment everywhere in Europe and North America.

The SCOPE International AG head office is Mannheim in Germany, with offices in 17 European countries and USA, covering 25 countries by own 138 full-time CRAs. With experience in neuroscience, psychiatry, pain/ analgesia, respiratory, oncology, hematology, dermatology, women’s health, immunology, and infectious diseases. This partner has experience a global inspections by the FDA, EMA, BfArM and local GCP inspections in Austria, Germany, Latvia, Portugal, Romania, Russia, Serbia, Slovakia, and the United Kingdom.

High focus on providing cost-effective and regulatory-compliant studies, within short timelines and on-time delivery, to support the approval of your products by EMA, FDA and other regulatory authorities.

Consortia

Blueclinical R&D is available to participate in international consortia candidate to Horizon 2020 calls or to other funding agencies.

Contacts

Daniela Mar, PhD, MBA
Deputy Business Development Director
dmar@blueclinical.pt