Existing Partners 5

BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.

BlueClinical is a privately-owned CRO, founded in May of 2012 with the aim of providing scientific consultancy and performing research & development activities for medicines, medical devices, diagnostics and other healthcare products.
BlueClinical is organized in 3 business units:
- BlueClinical Phase I: devoted to the conduct of bioequivalence and Phase I clinical trials in healthy subjects and selected patient population, which are carried out in our human pharmacology unit, located at Hospital da Prelada (Porto, Portugal).
- BlueClinical R&D: acts as a full-service CRO for clinical trials in patients in Portugal and Spain, and provides consultancy and standalone services in medical writing, clinical monitoring, pharmacometrics, regulatory affairs, pharmacovigilance, clinical data management, clinical data programming, biostatistics, project management.
- BlueClinical CRP (from “Clinical Research Partnership”): provides in loco clinical research site management services to 9 institutions belonging to the National Healthcare System. With the support of the other business units, it operates two Early Phase Clinical Trials Units (EPCTU) dedicated to Phase I studies in special populations (e.g., hepatic impairment, renal impairment) and Phase IIa studies (including proof of concept, POC) in target therapeutic indications.

Key information
Type: Full-service CRO especially focused on early phase clinical trials
Country: Headquarter in Porto, Portugal.
Directly covering Portugal and Spain.
Core activities:
  • All types of Phase I clinical trials with new molecular entities in healthy subjects: single- and multiple- dose escalation; drugdrug interaction; pharmacokinetics / pharmacodynamics; food effect; bioequivalence; thorough QT/QTc.
  • Pharmacokinetics in special populations (renal and liver impairment)
  • Bioequivalence studies based on pharmacokinetic endpoints or therapeutic endpoints.
  • Phase I/IIa studies (including proof of concept, POC) in patients with target therapeutic indications
Website: www.blueclinical.com
Aesculape CRO Belgium BV

Aesculape CRO is a small CRO with presence in Europe and Asia. We have offices in Belgium, Spain, Italy, Poland, Hungary, Singapore, Malaysia, India, Thailand, Vietnam, Indonesia and the Philippines. We are offering full services (with subcontracting DM activities) in most therapeutics domains (Oncology, CNS, Cardio metabolic, ID, NCE, Biosimilars, medical devices, nutraceuticals)

Key information
Type: Small CRO/medium CRO/ Bioanalytical Lab / Bioinformatics
Country: Belgium
Core activities:
  • Organisation and conduct of clinical trials
  • Real World Data
  • Real World Outcome
  • Health Outcome Research
Website: www.aesculape.com

Adax is a Slovenian Clinical Research Organization offering full range of clinical trial services in Slovenia, Serbia, Croatia and Bosnia. Adax was established in 1991 and has since then accumulated wealth of knowledge and experience managing clinical trials from phase I to IV including medicinal products, medical devices, advanced therapy medicinal products, gene therapy. By managing well over 100 clinical trials in last 10 years, having professional, motivated and young staff with low turnover rate is allowing us to appreciate trust of our current and future business partners.

In addition to activities in clinical trial setting we also offer regulatory support to medical device manufactures and authorized representatives, namely in preparing Clinical Evaluation Reports (CER).

Open communication, transparency and full support in joint ventures - these are Adax’s governing values.

Key information
Type: Small CRO
Country: Slovenia (headquarters), Serbia (registered office), Bosnia (registered office), Croatia
Core activities:
  • Management of clinical trials (phase I-IV) including site identification, contracting, regulatory support and submissions, clinical monitoring
  • eLearning portal offering GCP and medical device regulation trainings
  • Preparation of Clinical Evaluation Reports (CER) for medical devices
Website: http://www.adax.si/en/
Scientific ToolBox Consulting

Scientific ToolBox Consulting is a boutique CRO based in Portugal.

We specialize in the following areas:

  • Clinical Data Management,
  • Biostatistics,
  • Statistical Programming (including CDISC standards),
  • Medical Writing,
  • Clinical Operations (in Portugal).

Our clients are pharmaceutical, biotechnological and medical devices companies, other CROs, medical societies/associations and individual healthcare professionals (in investigator initiated

We support clinical research projects from design to report, in multiple therapeutic area, and in different research phases (from phase I to phase IV, BA/BE, pre-market/post-market).

Key information
Type: Small CRO/consultancy
Country: Portugal
Core activities:
  • Clinical Data Management,
  • Biostatistics,
  • Statistical Programming (including CDISC standards),
  • Medical Writing,
  • Clinical Operations (in Portugal).
Website: https://sctbx.com/en/

CW-Research & Management GmbH

Individuality instead of standard!
CW-R&M is an independent Contract Research Organization (Expert-CRO) certified according to EN ISO 9001:2015 and operating in the pharmaceutical, biotechnology, medical device and healthcare industry.

We employ a dedicated team of experienced specialists, which allows to support you with individual and tailor-made solutions. Our team is responsible for the implementation of numerous projects primarily in Austria and Germany.
Project-oriented and efficient working, accuracy, reliability or the ability of global and cross-linked thinking are just some characteristics of our employees. As their individual skills and know-how are crucial for the success of our company, continuous education and training ensure that knowledge and abilities are up-to-date.

Our expertise combined with more than 25 years of experience is the basis of our corporate philosophy and our success. Take advantage of our extensive experience, our professional and social skills as well as our flexibility.
Increase your resources by using the support of our specialists.

Key information
Type: Small Expert-CRO
Country: Austria, Germany
Core activities:
  • Clinical Operations & Regulatory Services
  • Monitoring & Study Assistance
  • Biostatistics & Coding
  • Data Management & Collection
  • Medical Writing
Website: www.cw-rm.com
NIZO food research

NIZO is a leading company in contract research for better food and health. Our focus is on the development and applications of innovations for the global food industry and related markets. Our Food department applies the newest food technology and processing knowledge. Our Health department supports companies in understanding and demonstrating health benefits of bioactive food ingredients, especially in the area of gut health and immune function. Our services include preclinical assays (digestion, gut fermentation, immune cell function, inflammatory markers) and food clinical trials with healthy volunteers, from protocol design up to data analysis, interpretation and reporting. To investigate immune protective effects of food ingredients in healthy individuals, we can use challenge models, that allow evaluation of either infection or vaccination response under strictly controlled circumstances. More than 20 years of experience in this field ensures a scientifically sound advice, taking into account the regulatory requirements for health claim substantiation.

Key information
Type: Small CRO
Country: Netherlands
Core activities:
  • Pre-clinical cell assays for immune function and inflammation
  • In vitro screening of gut microbiota changes
  • Design, management and reporting of food clinical trials
  • Microbiota composition and functionality
  • Bioinformatics to support and explain preclinical and clinical results
Website: http://www.nizo.com


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