What We Do
Protocol Development involves experienced professionals from the area of clinical sciences, medical and biostatistics to develop protocols to evaluate the required endpoints and apply appropriate statistical test to meet regulatory requirements for pharmacokinetic, pharmacodynamic and clinical efficacy studies. Our teamwork provides the resources necessary to develop protocols for new chemical entities, new indications and to develop innovative study designs.
Biostatistics and programming is a team of experts who are part of every clinical study, contributing from study design through compilation of a CDISC compliant report.
Biostatistics services include:
- Input into study design and sample size calculations
- Consultation during protocol development
- Generation of randomization schemes
- Assist in preparation of Statistical Analysis Plans (SAPs)
- Biostatistical analyses, including PK, PD, and efficacy data
- SAS Programming of Tables, Listings and Figures (TLFs)
- Quality Control of TLFs
- Input into the Clinical Study Report (CSR) for regulatory submissions to FDA, EMA and TPD
- Preparation of CDISC data sets (SDTM and ADaM)
Scientific Writing is a collaboration of our protocol and report writers, experts in field of medical and clinical sciences, clinical project managers and biostatisticians. They understand the importance of this phase of the clinical research process and are skilled at interpreting the data and presenting the results of the study.
- All reports are structured for submission to global regulatory agencies.
- Experienced team ensures that reports are prepared to FDA, EMA and TPD standards for NDA/ANDA submission.
- Clinical reports are created to comply with eCTD requirements in a submission ready format.