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SCITS.CO.IN

Call Us: 1300 140 589

Aus : 03 85211 508

Mon-Fri: 07:00 am – 06:00 pm

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eCTD services

SCIT works with the best and largest vendors who can deliver perfect results for customers
  • Development established centralized management services in compliance to all country regulators.
  • Development and compilation of regulatory dossier (eCTD, Non-clinical and clinical overviews, and summaries) compliance with country specific regulatory requirement.

Biostatistics

Spoorthy solutions’ eCTD domain is well equipped with professionals having strong academics besides having valuable scientific experience in various therapeutic areas

Randomization
Statistical Analysis Plan
Sample size estimation
Statistical Analysis
Trial Design Inputs

Statistical Reporting

We provide ON and OFF site services according to customer requirements, cost-effectively.

TLF Programming

CDISC Data Mapping (SDTM & ADaM)

Clinical Data Repository

Pooled Data Analysis & Reporting

Feasibility analysis

Safety (ADR) Reporting

Patient Profiles & Data Cleaning Reporting

Give timely responses to regulatory query

Help in SAP & TLG|F mock shell preparation | CDISC | SDTM | ADaM standards

Uploading for EDC | Blinded envelops

Stay informed about the up-to-date statistical techniques approved by regulatory authorities such as USFDA, EMEA and DCGI

Work on PK | PD Calculations

Evaluate statistical analysis & reporting

Provide preliminary results review

Get more value from your technology investment !

Schedule a consultation with our industry experts

More Services from Spoorthy Solutions

Application Management Service