eCTD Services

SCITS 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 requirements.

Biostatistics

Spoorthy Solutions' eCTD domain is well equipped with professionals having strong academics besides having valuable scientific experience in various therapeutic areas.

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Randomization

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Sample Size Estimation

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Trial Design Inputs

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Statistical Analysis Plan

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Statistical Analysis

Statistical Reporting

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

TLF Programming

Safety (ADR) Reporting

CDISC Data Mapping (SDTM & ADaM)

Patient Profiles & Data Cleaning Reporting

Clinical Data Repository

Give Timely Responses to Regulatory Queries

Pooled Data Analysis & Reporting

Help in SAP & TLG Mock Shell Preparation | CDISC | SDTM | ADaM Standards

Feasibility Analysis

Uploading for EDC | Blinded Envelopes

Stay Informed About Approved Statistical Techniques by USFDA, EMEA & DCGI

Work on PK | PD Calculations

Evaluate Statistical Analysis & Reporting

Provide Preliminary Results Review

eCTD services