DataClin CRO

We are an established all-phase contract research organization (CRO) based in Berlin, Germany.

We provide complete turn-key solutions for all stages of the clinical development process, including data management, biostatistics, clinical and medical monitoring as well as medical writing and pharmacovigilance services.

We are involved in several global clinical trials and – through collaboration with strong partners – has established a position at the forefront of the latest developments in the world of clinical research. We can manage complete clinical projects from initial trial inception through to regulatory submission.

Our experienced team has substantial expertise in the various divisions of clinical research which enables the company to offer services from preclinical to phase I-IV and post-marketing studies for pharmaceutical, biotech and medical device companies.

OCT is the leading contract research organization in Russia. Since 2005, OCT’s team has conducted over 300 clinical trials in Eastern Europe and the CIS region. Our team of 150+ clinical professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, infectious disease, and all major therapeutic indications.

As pharmaceutical and biotechnology companies have turned toward outsourcing models in clinical research, OCT has established itself as one of the top contract research organizations worldwide. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration, on time and within budget.

Our experienced team delivers a full range of CRO services:

Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Project Management and Monitoring
Drug Safety and Pharmacovigilance
Data Management
Biostatistics
Clinical Supply Services and Logistics
Marketing Authorization
GMP Inspection Support

Smooth Drug Development offers a full range of clinical trial, drug registration and post-marketing services, including consulting, development of registration strategy, conduct of clinical studies and pharmacovigilance. We cover wide geography:
-Russia
-Ukraine
-Belarus
-Kazakhstan
-Latvia
-Lithuania
-Estonia
-Serbia
-Slovakia
-Hungary
-Germany
-Spain

Our company implemented the principle of "one stop service" when all activities from planning to product registration are performed consistently under the control of a team of professionals. According to the requirements of ISO 9001:2015, in case of outsourcing of vendors we manage their activities as our ones and are fully responsible for the results.

Our Clients are leading pharmaceutical, biotech and R&D companies located in Europe, US, CIS and Asia-Pacific region.

We offer drug development services:
-Consulting center
-Pre-clinical research
-Clinical trials
-ePRO
-eTMF/eISF
-Drug registration
-Post-marketing surveillance
-Pharmacovigilance
-Training center

We are experts in clinical services:
-Project management
-Medical writing
-Feasibility and site selection
-Regulatory support
-Data management
-Logistics and storage
-Clinical monitoring
-Medical monitoring
-Pharmacovigilance
-Bioanalytical and central laboratories
-Biomedical statistics
-Clinical study report
-GCP audit

Smooth Drug Development has unique IT solutions for clinical trials which help to speed up clinical trials processes and daily activities. Smooth CTMS includes the following modules:
-EDC/eSource/IWRS
-eTMF/eISF
-ePRO
-Learning / QMS
-Personal Folder
-Clinical Monitoring

Smooth Drug Development has been ISO certified:
-ISO 9001:2015 Quality Management Systems
-ISO 27001:2013 Information Security Management Systems
-ISO 22301:2019 Business Continuity Management Systems

Smooth Drug Development works with Life Science Marketplace. Find us there.

Please contact us at bd@smoothdd.com to learn more about Smooth Drug Development capabilities.

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.

Sign-up to receive invites to webinars, training courses and the latest cutting-edge information on clinical trials: https://go.pardot.com/l/129231/2020-07-27/39ng9k

CliniRx is a global Clinical Research Organisation with deep regional experience. CliniRx offers ICH-GCP compliant clinical trial services from Phase I – IV in key therapeutic areas to support clinical development requirements. We have offices and operational capabilities in India, US and UK.

We offer end to end services starting from conduct of Feasibility Studies, Study Planning to Regulatory Submissions, Site Evaluation and Selection, Site Monitoring, Project Management, Medical Monitoring, Pharmacovigilance, Clinical Data Management, Data Analysis, Medical Writing and Quality Assurance.