Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.
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ANTAEA Group of Companies is one of the largest Regional Clinical Research Organizations (CROs), providing high quality support in Southeast Europe, North Africa, Middle East and the Gulf Area.
The Group provides professional, yet flexible solutions, supporting our Clients to maximize their Research resources, in a cost effective manner. ANTAEA is dedicated to Services of scientific quality, management expertise, precision and reliable technology.
The Group includes integrated, marketing consultation services in our portfolio, based on Market Research, which cover products throughout their life cycle.
Specialities: Feasibility Projects, Initial Submissions, Amendments and Notifications to ECs (local and central) and Regulatory Authorities, Clinical Trials Monitoring in several different phases, Contracts for Clinical Trials Management, Contracts for Clinical Trial Rescue Projects, Design and Development of Clinical Trials Projects, Investigator Initiated Projects, Regulatory & Registration Projects (National, MRP, Variations etc.), Statistical Projects, Contracts for Investigator Training, Contract for Regulatory Services Training, Contract for Site Audit
ANTAEA also provides experienced CRAs to the Pharmaceutical and Biotechnology Industries and to CROs, in all the countries where ANTAEA is operating. ANTAEA training on procedures and setting standards and our technical support, guarantee uniformity in quality and timely delivery of projects.
Appletree CI Group is an expert niche CRO/CSO and global regulatory affairs service provider with track records in ophthalmology and medical device investigations. We are present in 11 European countries and have over 30 permanent staff. By having an in-depth understanding of local cultures and customs, as well as experience with national regulations we are able to facilitate your clinical development and regulatory projects.
- Clinical trials phases I-IV
- site feasibility, evaluation and initiation
- monitoring services, close out
- Medical writing
- Clinical trial authorizations Europe
- Marketing authorization applications
- Life cycle management, variations management
- Scientific advice
Cromos Pharma is an international CRO with expertise in delivering all aspects of clinical trials in all clinical phases and a range of therapeutic areas.
Cromos Pharma offers fully integrated CRO services including regulatory consulting and compliance, project management; monitoring; medical writing; data management and biostatistics; drug and device registration services; logistics and warehousing; post-marketing services and independent audits. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management.
Cromos Pharma's "No Patients - No Payments" initiative allows the sponsors to pay for performance and is our guarantee that the study timelines will be met.
Established in Moscow in 2004, Cromos Pharma has strong regional presences in Central and Eastern Europe, Russia and Post-Soviet Bloc countries. Its European HQ is situated in Dublin, Ireland and its US base is in Portland, Oregon.
Fountain Medical Development is a clinical contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services in China, US, Japan, and Europe. FMD has extensive global experience in multiple therapeutic areas. The company has completed dozens of registrations trials which supported marketing authorization applications in US and Europe.
Our people is the basis of our success. The 1,700+ professionals are dedicated and diverse. At any given moment, at least 3 languages are spoken in our 20 offices in Asia, US, and Europe.
FMD is on the forefront of the paradigm shift in global clinical development. The regulatory reform in China has the potential to fundamentally change how an innovative therapy is developed. FMD is on the frontline building and shaping the future.
FMD is large enough to serve 7 out the 10 largest Pharma companies, and nimble enough to customize to the needs of startup firms.
In the US and Europe, FMD is doing business as FMD K&L. In China, we operate under the name FMD. Whatever the names are, the company is managed globally by a seasoned senior management team comprised of industry veterans.