SIGMA medical writers team performs medical, scientific and regulatory writing as well as consulting. Documents designed by medical writers: Study Protocol, Investigator Brochure, Informed Consent Form, Clinical Study Reports, Registration Dossiers, Scientific Articles.

Our highly qualified Regulatory team will have you covered through all phases of clinical trials – from preclinical approval to post-marketing activities to ensure complete regulatory support for your product. This includes obtaining of clinical trial (CTA) approval, insurance management, obtaining of import and export licenses, amendments and notifications submission, EC submissions, consulting.

All CRAs have either medical or life sciences background.

They receive regular training in ICH Good Clinical Practice (GCP) and the company’s standard operating procedures.

Clinical monitoring services include, whilst not limited to:

• Feasibility and site identification and assessment;
• Local Ethics committee submissions preparation and support;
• Translation of study-specific documents including quality check;
• Assistance in obtaining local insurance;
• Training of investigators and sites’ teams (e.g. GCP, safety reporting, IMP handling, protocol, etc.);
• Clinical trial oversight in order to assure compliance with the protocol and applicable regulatory requirements;
• Accurate source data verification for reliable clinical data;
• Site support on prompt recruitment process;
• Trial Master File compilation, review and maintenance;
• Investigational Medicinal Product (IMP) and Clinical Trial Materials (CTM) coordination;
• Support during site audits and inspections.

Project Management team consists of high experienced PMs who is responsible for managing your study from study award and within study initiation, planning, execution, monitoring and control and closure phases. All PMs have medical background. PM responsibilities include the following:

• serve as a main contact for Sponsor
• coordinate project team
• vendors management
• preparation of study plans and project documentation
• ensure trainings performed for project team
• ensure study milestones achieved on time
• managing study according to study timelines and budget
• risks management
• regular reporting to Sponsor on project status

We provide dedicated clinical data management services from database build to database lock and archiving.

Our primary goal in biostatistics services is to provide accurate, high-quality, and timely biostatistics services, including statistical planning, analysis, and reporting.

We offer the full suite of pharmacovigilance services to ensure regulatory compliance and patient safety during the whole drug development process.

We provide support in drug registration in Russia.