Regulatory
Affairs
The space for data analysis
Choose the CRO with vast experience in data analysis by CDISC standards
About us
TUNECT is the contract research organization (CRO)
We provide a range of biopharmaceutical services that help our clients transform scientific discoveries into new treatment methods.TUNECT headquarter is located in NY, USA.
Solutions highlights
We don't just make your project
We develop individual solutions that help improve the health and well-being of many people around the world.
Data
Sciences
Safety and
Pharmacovigilance
Clinical
Operations
Quality
Assurance
We provide expert project management to ensure the success of your clinical research
Our team is committed to delivering high-quality, compliant outcomes for all your study needs.
- Sample size calculation and justification
- Protocol development and review
- Randomization schedule development
- CRF and SAR review
- SAP preparation
- TFLs shells development
- Statistical analysis and report preparation
- SDTM and ADaM
- Reviewers guidelines
(SDRG and ADRG) development
- Sample size SAS codes development
- Randomization schedule SAS codes development
- Implementation of data management plans and approved SAP
- CRF annotation
- Development of specifications for analysis datasets
- Preparation and finalization of SAS programs for SDTM/ADaM datasets and TFLs
- Datasets validation according to CDISC
- Define.xml development
- Clinical trial design
- Endpoints justification
- Protocol development and review
- Supporting Clinical trial from study planning till CSR registration
- Clinical Study Report (CSR) development
- Articles and publications
- Database planning and development
- Database administration
Preparing the database for interim/ final analysis - Medical/ pharmaceutical coding
- Database lock
- Serious Adverse Events (SAE) Reconciliation
- Data archiving
- Sample Consulting
- Ability to find a professional for your requirements (therapeutic area/study phase/etc.):
- Junior SAS Programmers
- Middle SAS Programmers
- Senior SAS Programmers
- Junior Biostatistician
- Middle Biostatistician
- Senior Biostatistician
- Junior DataManager
- Middle DataManager
- Senior DataManager
- Middle Medical Writer
- Senior Medical Writer
Sample size calculation and justification
Protocol development and review
Randomization schedule development
CRF and SAR review
SAP preparation
TFLs shells development
Statistical analysis and report preparation
SDTM and ADaM
Reviewers guidelines
(SDRG and ADRG) development
Sample size SAS codes development
Randomization schedule SAS codes development
Implementation of data management plans and approved SAP
CRF annotation
Development of specifications for analysis datasets
Preparation and finalization of SAS programs for SDTM/ADaM datasets and TFLs
Datasets validation according to CDISC
Define.xml development
Clinical trial design
Endpoints justification
Protocol development and review
Supporting Clinical trial from study planning till CSR registration
Clinical Study Report (CSR) development
Articles and publications
Database planning and development
Database administration
Preparing the database for interim/ final analysis
Medical/ pharmaceutical coding
Database lock
Serious Adverse Events (SAE) Reconciliation
Data archiving
Sample Consulting
Ability to find a professional for your requirements (therapeutic area/study phase/etc.):
- Junior/ Middle/ Senior/ Principle SAS Programmers
- Junior/ Middle/ Senior/ Principle Biostatistician
- Junior/ Middle/ Senior/ Principle Data Manager
- Middle/ Senior Medical Writer
Strategic Partnerships
We collaborate with premier medical centers and laboratories
We work closely with leading medical centers around the world, focusing on volunteer recruitment and the management of clinical trials.
Our top-tier laboratory collaborations offer comprehensive services, ensuring high standards for your research.
and more
