Clintrex
CLINTREX is a clinical research company specializing in CNS diseases, providing integrated expert services to help develop new treatments efficiently. They focus on neurodegenerative diseases, MS, epilepsy, and migraine, utilizing their international reputation and the SMART CLINICAL TRIALS approach to optimize clinical study outcomes.
Industries
Nr. of Employees
small (1-50)
Clintrex
Products
CNS Drug Development Consulting Services
Clinical research advisory services specializing in CNS diseases with expertise in neurodegenerative diseases to help design clinical trials and address regulatory issues.
The CLINTREX Encounter
An interaction between biotech or pharma company members and CLINTREX experts providing personalized regulatory and development guidance, including regulatory pathway outlines, development plans, or protocol synopses.
SMART CLINICAL TRIALS approach
A comprehensive clinical trial service designed to minimize error, optimize subject selection, reduce sample size, and increase the chances of obtaining accurate and reliable study results efficiently.
Clinical Trial Design and Execution
Service for designing and executing clinical trials.
On-Going Monthly Services
Ongoing clinical, regulatory, and business development services provided under a monthly fee, including study design, site training, enrollment, regulatory support, and statistical analysis.
Milestone Based Projects
Individual project-based consulting services including protocol writing, NDA document preparation, regulatory meeting participation, due diligence, and white paper creation.
CNS Drug Development Consulting Services
Clinical research advisory services specializing in CNS diseases with expertise in neurodegenerative diseases to help design clinical trials and address regulatory issues.
The CLINTREX Encounter
An interaction between biotech or pharma company members and CLINTREX experts providing personalized regulatory and development guidance, including regulatory pathway outlines, development plans, or protocol synopses.
SMART CLINICAL TRIALS approach
A comprehensive clinical trial service designed to minimize error, optimize subject selection, reduce sample size, and increase the chances of obtaining accurate and reliable study results efficiently.
Clinical Trial Design and Execution
Service for designing and executing clinical trials.
On-Going Monthly Services
Ongoing clinical, regulatory, and business development services provided under a monthly fee, including study design, site training, enrollment, regulatory support, and statistical analysis.
Milestone Based Projects
Individual project-based consulting services including protocol writing, NDA document preparation, regulatory meeting participation, due diligence, and white paper creation.
Services
Review of preclinical efficacy, safety, toxicology, pharmacokinetic, and target engagement data and assistance designing additional studies to support clinical development.
Assessment of therapeutic landscape and creation of development pathways, including selection or augmentation of clinical operations teams and overall program planning.
End-to-end protocol design, site and investigator selection, investigator training, enrollment committees, database management, SAP creation, monitoring, and oversight of trial execution; includes approaches to minimize variability and sample size.
Regulatory strategy development, briefing package review, participation in regulatory meetings (pre‑IND, end of phase 2, SPA, pre‑NDA), assistance with clinical holds, and responses to RTFs/CRLs; includes mock advisory committee participation.
Preparation and review of protocols, informed consents, clinical study reports, and regulatory clinical documents (e.g., Integrated Summaries of Safety/Efficacy); manuscript and publication support.
Due diligence on new assets, disease and market information for investors, and support for partnering and financing activities.
Review of preclinical efficacy, safety, toxicology, pharmacokinetic, and target engagement data and assistance designing additional studies to support clinical development.
Assessment of therapeutic landscape and creation of development pathways, including selection or augmentation of clinical operations teams and overall program planning.
End-to-end protocol design, site and investigator selection, investigator training, enrollment committees, database management, SAP creation, monitoring, and oversight of trial execution; includes approaches to minimize variability and sample size.
Regulatory strategy development, briefing package review, participation in regulatory meetings (pre‑IND, end of phase 2, SPA, pre‑NDA), assistance with clinical holds, and responses to RTFs/CRLs; includes mock advisory committee participation.
Preparation and review of protocols, informed consents, clinical study reports, and regulatory clinical documents (e.g., Integrated Summaries of Safety/Efficacy); manuscript and publication support.
Due diligence on new assets, disease and market information for investors, and support for partnering and financing activities.
Expertise Areas
- Clinical trial management
- Regulatory strategy and regulatory interactions
- Biostatistics and clinical data management
- Preclinical study design for clinical translation
Key Technologies
- Adaptive and complex clinical trial design
- Centralized randomization and enrollment adjudication
- Statistical analysis planning (SAP)
- Clinical database systems and data management
News & Updates
The Clintrex Experience
CLINTREX has provided advisory services to over 150 companies, led clinical trials, and supported regulatory interactions including FDA, EMA, and others.
The Clintrex Experience
CLINTREX has provided advisory services to over 150 companies, led clinical trials, and supported regulatory interactions including FDA, EMA, and others.