Our services

We provide stand-alone as well as fully-integrated services to the biotechnology and pharmaceutical industry, with a particular focus on rare and orphan diseases as well as biotherapeutics and advances therapies.

Clinical Research​

From study design to execution

We are aware that our experts can be strong assets in the development of new drugs for patients. We therefore owe it to wisely ourselves not only to select them according to the needs of our clients, but also to support them and to train them throughout their missions.

Study Design

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Study Design

• Synopsis Development
• Sample Size Stat Power
• Protocol Writing
• Statistical Section of Protocol
• Clinical Development Plan
• Feasibility Studies

Project Management

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Project Management

• Oversight
• Patient Identification / Sourcing
• Vendor Selection
• Investigators Fees Management
• Patient Fees Management
• Coordination & Communication
• DSMB - Experts Board Management

Regulatory Affairs

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Regulatory Affairs

• CTA Application
• IMPD
• CMC
• PIP
• IND
• Scientific Advice
• Briefing Book

Regulatory Submissions

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Regulatory Submissions

• Gap Analysis
• Coordination with Local Authorities
• Documents Review and Preparation
• Protocol Review and Translation
• Submission and Follow Up

Clinical operations

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Clinical Operations

• Trainings
• Site Qualifications Visits
• Site Initiation Visits
• Monitoring Visits
• Close Out Visits
• CRAs Management & Coordination
• Recruitment & Direct-to-Patient

Data management

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Data Management

• CRF Design
• Data Management Plan
• DataBase Set Up
• Data Cleaning
• eCRF
• ePRO
• DataBase Lock
• Medical Review

Biostatistics

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Biostatistics

• SAP
• TFLs Generation
• Statistical Review of TFLs
• Stat Report
• Submission Package

Medical writing

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Medical Writing

• Narrative Drafting & Review
• Clinical Study Report
• Publication

Consulting

Clinical Development

  • Medical affairs
  • Clinical development strategies
  • Management of data monitoring boards & steering committees
  • CTA regulatory submissions and follow-up with Regulatory Authorities
  • Drug safety and pharmacovigilance
  • ​Trainings in the businesses of pharmaceutical industry: ICH-GCP

Medical affairs

  • Medical plans & strategies
  • Management of medical and KOL boards  
  • Medical communication
  • Medical writing
  • Market access and market development