Planning
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Reporting
ME-TA provides the service of statistical reporting of clinical trials and creating corresponding submission ready datasets, delivering data according to CDISC standards and statistical outputs according to ICH E3. The service is provided using ME-TA systems and procedures (SOPs).
Metawebservice
Services where the use of Metawebservice complements our experience and skill-set to achieve better results
ME-TA has a vast experience in planning for success and can assist with CRO services like
- Study design.
- Clinical development plan optimization.
- Study simulation.
- Protocol/SAP development.
- Quantifying the uncertainties in market value.
- Assessment of the possible competitors at the time of launch.
ME-TA has a vast experience in clinical reporting and can assist with many of the standard CRO services including:
- Sample size calculations.
- Protocol input and review.
- Generation of randomization lists.
- Writing of statistical analysis plan.
- Statistical reporting and exploratory analysis.
- CDISC compliance (SDTM and ADAM datasets with supporting documentation).
- Creation of end of text material for study reports.
- Integrated analysis for regulartory submission (ISE & ISS).
- HTA statistical packages for payer submission.
Services where we excel
Metawebservice is the validated development platform we use at ME-TA. We purposely built Metawebservice to complement our skill-set and to accommodate the kind of relationship we want with our customers.
Metawebservice gives us a comparative advantage in services where
- Some form of automation benefits the service.
- Secure distribution of individual files to third-parties is a requirement.
- A large volume of outputs needs to be produced efficiently.
- A high degree of customer collaboration is required.
- A Customer requires draft deliverables be available instantly for internal systems.
Below we highlight two of such services
HTA submission packages
HTA statistical package for Payer submissions has been a focus area for ME-TA the last couple of years. Here our experience needs to be complemented with a version-controlled repository which can handle the large amount of outputs which are produced when doing analysis by population*pool*subgroup*outcome. Metawebservice was built for that purpose.
DMC packages
ME-TA has a lot of experience in creating data packages for data monitoring committees. ....