Biostatistics and Statistical Programming have become essential components of modern clinical research and development. Clindata Insight provides industry-leading expertise in biostatistics and statistical programming. Our team has many years of trial experience from phase I to submission. We also have over 10 years of CDISC experience and in-depth knowledge of multiple therapeutic areas, especially in oncology. Our service area includes:
Service Area 1
Biostatistics & Statistical Programming
- Study Design Consultation
- Randomization
- SEND
- Statistical Section Protocol
- SDTM
- ADaM
- Tables, Figures & Listings
- e-Submission
- Statistical Analysis Plan
- Integrated Efficacy & Safety
- Clinical Study Report
- Regulatory Filing
Service Area 2
Clinical Data Management
We pride ourselves on our ability to bring technology, knowledge, and experience in clinical data management (CDM) consulting service to our clients. Our CDM team will provide customized, cost-effective, and high-quality deliverables.
Our clinical data management consulting service includes:
- Data Management Plan
- CDASH
- Medical Coding
- CRF Design
- Edit Check Programming
- Reconciliation
- Database Build
- Query Management
- Reporting
Service Area 3
CDISC Standards Implementation
All clinical trial studies starting after December 17th, 2016, with the exception of certain INDs, will be required to have CDISC compliant data. Any clinical trial data that is not submitted in CDISC format to the FDA can lead to a delay of submission or a “refuse to file” by the FDA.
At Clindata Insight, we have seasoned CDISC subject matter experts to help you achieve compliance.
