Services
Services
Clinical Operations / Study Conduct
Neurotrials helps you design, start-up and manage your clinical trials to successful completion.
- Clinical operations activities : Site selection, initiation, monitoring, close out.
- Data management
- Biostatistics
- Pharmacovigilance
- Quality assurance
Scientific and Medical Consulting
Our highly scientific team provides you with the knowledge foresight and expertise to conduct your project
- Scientific consulting before starting clinical trials : Identification of product strenghts and weaknesses, refinement of scientific rational, product positioning
- Scientific advices
- Protocol design and clinical trial planning
- Develop key opinion leaders (KOLs) and advisory panel networks
Clinical Operations / Study Conduct
Neurotrials helps you design, start-up and manage your clinical trials to successful completion.
- Clinical operations activities : Site selection, initiation, monitoring, close out.
- Data management
- Biostatistics
- Pharmacovigilance
- Quality assurance
Scientific and Medical Consulting
Our highly scientific team provides you with the knowledge foresight and expertise to conduct your project
- Scientific consulting before starting clinical trials : Identification of product strenghts and weaknesses, refinement of scientific rational, product positioning
- Scientific advices
- Protocol design and clinical trial planning
- Develop key opinion leaders (KOLs) and advisory panel networks
Regulatory affairs
Our regulatory affairs experts guide you through the entire product development and regulatory submission process to help you achieve regulatory success.
Neurotrials provides strategic and operational support for regulatory activities and development of the documentation.
- Submissions to Competent Authority and Ethics Committee
- Communication with regulatory agencies
- Response to agency reviewers
- Regulatory briefing documents for agency meetings, including: EMA and national Scientific Advice procedures and pre-submission meetings.
- Orphan Drug Designation Application
- ATMP classification application
Medical Writing
Medical writers are critical to communicate goals, strategies, results and analyses of a clinical trial/program to investigational sites, sponsors, regulatory authorities and patients.
Neurotrials provides medical writing support for the full life cycle of a product‘s development, beginning with early-stage development.
- Synopses, Protocols and Amendments
- Informed Consent Forms
- Safety narratives
- Clinical development plans, Clinical study Reports (CSRs)
- Investigator Brochure and Patient information leaflets
- Annual reports
- Periodic and development safety update reports (PSURs and DSURs)
- Periodic benefit-risk evaluation reports (PBERs)
Regulatory affairs
Our regulatory affairs experts guide you through the entire product development and regulatory submission process to help you achieve regulatory success.
Neurotrials provides strategic and operational support for regulatory activities and development of the documentation.
- Submissions to Competent Authority and Ethics Committee
- Communication with regulatory agencies
- Response to agency reviewers
- Regulatory briefing documents for agency meetings, including: EMA and national Scientific Advice procedures and pre-submission meetings.
- Orphan Drug Designation Application
- ATMP classification application
Medical Writing
Medical writers are critical to communicate goals, strategies, results and analyses of a clinical trial/program to investigational sites, sponsors, regulatory authorities and patients.
Neurotrials provides medical writing support for the full life cycle of a product‘s development, beginning with early-stage development.
- Synopses, Protocols and Amendments
- Informed Consent Forms
- Safety narratives
- Clinical development plans, Clinical study Reports (CSRs)
- Investigator Brochure and Patient information leaflets
- Annual reports
- Periodic and development safety update reports (PSURs and DSURs)
- Periodic benefit-risk evaluation reports (PBERs)
Neurotrials is part of an eco-system promoting performance and safety. We bring you the best of both the industrial and academic worlds to improve your product development
Neurotrials is part of an eco-system promoting performance and safety.
We bring you the best of both the industrial and academic worlds to improve your product development