Existing Partners 2

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
Global Clinical Trials, LLC

Global Clinical Trials (GCT) is a full-service premium Contract Research Organization (CRO) supporting Phase I-IV clinical, medical device studies and post-marketing activities for Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions.

Key information
Type: Medium CRO
Country: USA, Bulgaria, Estonia, Georgia, Hungary, India, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Russia, Ukraine
Core activities:
  • Clinical Monitoring
  • Regulatory
  • Project Management
  • Site Management
  • Legal Affairs
Website: https://gctrials.com/
Poseidon CRO

Poseidon CRO has a unique in class geographical coverage including North Africa, Western Balkans and Hungary. We have an extensive network of collaborating sites and maintain a solid relationships with Key Opinion Leaders in all our regions. This is allowing us to perform all kinds of clinical trials, health market research studies, Outcome Research, patient support programs and pharmacoeconomics.
Our comitted team has a strong knowledge in regulatory processes and clinical operations and is used to manage efficiently the most complex and demanding trials, thanks to a continuous improvement policy, embedded since the start in the companie's culture. We gained experience in various therapeutic areas such as oncology, diabetes and metabolic diseases, cardiology, respiratory, central nervous system, infectious diseases, ophthalmology, gastroenterology and gynaecology.

Our team is also providing medical translation of content allthrough the drug/medical device life cycle in English, French, Serbian, Arabic and Hungarian.

Key information
Type: Small CRO
Country: Tunisia, Morocco, Serbia, Montenegro, Hungary
Core activities:
  • Regulatory and contracting/Site management in North Africa, Balkans and EU
  • Monitoring/Clinical operations/Pharmacovigilance
  • Patient oriented programs/Medical information
  • Out/in Lincensing for drugs and medical devices
  • Market Access/HEOR studies
Website: www.poseidoncro.com
MyCRO Sağlık Hizmetleri

Founded in Ankara in 2016, MyCRO's mission is to provide the highest quality at every stage of clinical research. We are bringing to you our 8 years of clinical research logistics support, and 10 years of experience in Clinical Research management in phase III and IV, Observational studies and medical device studies.

We are aware of the great potential of Turkey in clinical research, and with our past experiences, we are committed to high standards of quality and customer satisfaction in the future.

MyCRO logo
Key information
Type: Small CRO
Country: Turkey
Core activities:
  • Site management
  • Project management
  • Feasibility evaluation and site choosing process
  • Logistic support
  • Phase I - IV studies
Website: https://mycro.com.tr/

Klinar CRO

Klinar CRO was established as an Optimum CRO enterprise for the international trials conducted in Turkey. Both companies are conducting clinical trials since September 2000 in Turkey.
Our companies has a deep experience over the clinical trials of different phases and types and post-marketing surveillance studies.
With our extensive background in this field, our specialized team and with the philosophy of continuous improvement, we are ensuring to provide the services you need with the excellent process.

Klinar CRO has become one of the first certified CRO to be approved by the Ministry of Health in Turkey, working in compliance with the principles of “Guideline For Good Clinical Practices”.

Key information
Type: Small CRO
Country: Turkey
Core activities:
  • Project Management
  • Study Monitoring
  • Site Management
  • Regulatory Affairs
  • Training.
Website: www.klinar-cro.com
Zi Diligence Biocenter

Zi- Diligence is a leading biocenter in Egypt and the Middle East. Our Company offers a variety of services including Bioequivalence studies, Biowaver studies, and other pharmaceutical research services.

1st GCC accredited Biocenter in Egypt and 36th worldwide in addition to ISO 9001 & ISO 17025 certificates.

All studies are conducted under strict adherence to GCP & GLP principles in accordance with EMEA, FDA, ICH and WHO, with controlled calibrated equipments.

Key information
Type: CRO
Country: Egypt
Core activities:
  • Bioequivalence and bioanalysis
  • Invitro studies
  • Pharmacokinetics
  • Formulation
  • Consultation
Website: www.zi-diligence.com

Clinical Trials Group (CTG) is a privately owned independent Contract Research Organization (CRO) based in CEE region. For more than 20 years already, many companies have been benefiting from CTG’s global and local scientific, regulatory and management expertise, achieving timely and high-quality clinical trials data. With an experienced and reliable team on board, CTG is specialized in conducting all phases (I-IV) clinical trials in various therapeutic areas, confirmed as a trusted partner in medical research, which is enforced by our quality personalized services.
Clinical trials are planned, conducted and evaluated based on scientific criteria, which are in accordance with the legal framework, national and international guidelines, ICH GCP and SOPs.

CTG combines the advantages of a regional CRO – cost effectiveness, local knowledge, personal services, flexibility – with the expertise and understanding that comes from a history of managing global clinical trials to the highest quality standards throughout the world. The directors of CTG are committed to being personally involved in the oversight of the work being performed by CTG personnel.

CTG has Proven Record of Quality, Broad Experience and Expertise, we have been audited by sponsors (30 audits) and inspected by regulators (6 inspections, including FDA in 2011 and 2013).
Our headquarter is located in Bucharest, Romania and we have offices in Israel, Poland, Moldova, Bulgaria, Serbia, Croatia, Montenegro, Bosnia and Herzegovina and Slovenia, also via partnering organizations we are present in Greece, Turkey, Macedonia, Poland, Hungary, Slovakia, and Check Republic.

Key information
Type: Medium CRO
Country: Romania
Core activities:
  • Product development
  • Project Management
  • Regulatory Affairs
  • Site management
  • Clinical Monitoring
Website: www.ctgcro.com
Gaea OÜ and Gaea Trial Acceleration OÜ

Gaea was established in 1994 as a clinical consultancy committed assist in the development of clinical development plans, and project management within sponsors.

Gaea is now a full-service agile CRO, working in complex indications and IMPs, where experience matters, serving all of Europe and the Russian Federation.

Gaea is also a trial acceleration company, to get slow trial sites moving in screening and enrolment leaving the CRO to manage the data.

Key information
Type: Small CRO and Trial Acceleration Company
Country: Estonia
Core activities:
  • Full services CRO
  • Clinical consultancy
  • Trial acceleration
Website: www.gaeaou.com

Clingroup was established in France since 2002, and expanded our activities through middle east & Africa ( MEA) – so, we are offering our 17-year European expertise
We are operating our business from 2 main locations, Egypt & Lebanon, while joint ventures with numerous partners from Morocco to Pakistan East and from Armenia to South Africa South.

Clingroup is first NPO ( non profiting organization ) in MEA, as all our profits going for HOPE mcf (www.hopemcf.org) as our values and mission of our social responsibilities.

Our global presences with our projects approvals from Ministry of health in a lot of countries and FDA assures the wide range of studies and services we could do in a lot of criteria.
We are ISO compliant from France since 2009, and regarding our strong internal audit which leads us now to be even external audits by our qualified teams on other CROs. Even although we had been audited successfully by our clients from worldwide.

Key information
Type: Medium CRO
Country: Egypt & Lebanon - covering by its activities Middle East, Gulf, Africa
Core activities:
  • Clinical Trials ( Phase 1 to Phase 5 ) - BE – PK/PD studies
  • Feasibilty assessment Site Identification on /off site - Project Management
  • Patient Outsourcing
  • Clinical Research Units Setup – Staff training – SOP writing
  • Phamacovigilance & Nutricoviglance System setup – Literature screening – CTD / E-CTD - Call centers – Adverse effects reporting
Website: www.clingroup.net
PHArmaceutical Research Management (PHARM) SRL

PHArmaceutical Research Management (PHARM) SRL is a private enterprise established in 2011 with the mission of stimulating and facilitating Pharmaceutical Companies to invest in neglected therapeutic areas (i.e. pediatrics, rare disorders, advanced therapies).

PHARM SRL is registered as a Contract Research Organisation – CRO by AIFA (Italian Medicines Agency), pursuant to and in accordance with the Italian Ministerial Decree 15/11/2011, offering experience and support in all management, organizational, strategic, regulatory, biostatistics, methodological aspects of drug research development, in compliance with applicable regulations and GXPs. It is a member of the Italian Association of CROs (AICRO) and belongs to Scientific Networks promoting clinical trials.

Key information
Type: small CRO
Country: Italy
Core activities:
  • Regulatory and Ethics activities
  • Planning and coordination of GCP clinical trials
  • Data management
  • Pharmacovigilance
  • Monitoring and auditing
Website: http://www.pharmsrl.com/

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