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
23501 Cinco Ranch Blvd, Suite H210, Katy, TX 77494
Products
Clinical Trial Design and Execution
Designs and executes clinical trials, ensuring optimal entry criteria, outcome measures, sample size, and compliance with regulatory requirements.
Regulatory Support/Strategy
Provides support and strategies for regulatory pathways, including approaches to FDA meetings, potential indications, and product filing issues.
Pre-Clinical Development
Assists in pre-clinical studies that guide human trial design, including toxicology and pharmacokinetic studies.
Medical Writing With Disease-specific Expertise
Offers medical writing services with expertise in specific diseases, particularly neurodegenerative diseases.
CMO Services
Acts as Chief Medical Officer for companies, providing leadership in clinical development, medical affairs, and regulatory affairs across all phases of development.
Business Development/Due Diligence
Assists with business development and due diligence activities, including evaluating preclinical results and participating in regulatory meetings.
Clinical Trial Design and Execution
Designs and executes clinical trials, ensuring optimal entry criteria, outcome measures, sample size, and compliance with regulatory requirements.
Regulatory Support/Strategy
Provides support and strategies for regulatory pathways, including approaches to FDA meetings, potential indications, and product filing issues.
Pre-Clinical Development
Assists in pre-clinical studies that guide human trial design, including toxicology and pharmacokinetic studies.
Medical Writing With Disease-specific Expertise
Offers medical writing services with expertise in specific diseases, particularly neurodegenerative diseases.
CMO Services
Acts as Chief Medical Officer for companies, providing leadership in clinical development, medical affairs, and regulatory affairs across all phases of development.
Business Development/Due Diligence
Assists with business development and due diligence activities, including evaluating preclinical results and participating in regulatory meetings.
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.