Techsol provides centralized clinical data management services for Phase I to Phase IV clinical studies across various therapeutic areas with a comprehensive risk-based and value-focused data management plan. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies, we provide end-to-end clinical data management support starting from eCRF design to database lock and final study archival.

How We Help Sponsors With Clinical Data Management

All our CDM processes are governed by stringent SOPs and Work Instructions that ensure ICH-GCP compliance.

Activities We Perform

  • Protocol Review
  • Study Data Needs Assessment
  • Data Management Plan Preparation
  • Clinical Trial Case Report Form (CRF) Development
  • Patient Diary Design
  • Data Validation Plan Preparation
  • Data Quality Oversight Plan

Our CDM team has worked on a wide-range of therapeutic areas and have worked using different types of EDC applications. We adopt CDASH for CRF Design and CDISC – SDTM Standards for study database build.

Activities We Perform

  • CRF Annotation
  • Study Database build in EDC System (Program, Sites, Visits, Subjects, CRFs, External data forms, etc.)
  • IWRS Study Randomization System Integration with EDC
  • Complete Edit Checks Programming for Study Data Validation
  • Perform Study Database User Acceptance Testing
  • Provision EDC System Access to Site & Study Personnel
  • Deliver EDC System Training & Certification to Principal Investigators and Site Personnel

To deliver high quality clinical trial data, we have established comprehensive reports and metrics on Query Management, Trial Progress Summary (Subject, Sites, Visits, etc), Data Acquisition Trends and Data Quality Oversight Metrics to track overall progress of data collection, data validation and progress towards study database lock

Activities We Perform

  • Site Data Entry Oversight
  • Data cleaning
  • Source Data Verification & Risk-based Monitoring
  • External Data Loading (Labs, ECG, Patient Diary Information, etc.)
  • Query Resolution Management
  • Query Aging
  • Ongoing Data Quality Control
  • Medical Coding (MedDRA, WHO-Drug, SnoMed, etc.)
  • Post-production Study Database Changes
  • SAE Reconciliation
  • Data Listing Transfer & Review
  • DM Metrics & Status reports

We derive additional value from Data and provide inputs to Clinical Operations team on:

  • How to minimize Protocol Deviations & Violations based on data point patterns and anomalies
  • Identifying AE & SAE Trends that can be reviewed by Data Monitoring Committee
  • Enriching Study Endpoints with derivations that will be useful for statistical analysis

Activities We Perform

  • Resolve all Outstanding Queries across Sites, CRAs, and DM Review
  • Complete approved CRF data updates
  • Final medical coding (MH, AE, CM) & perform SAE Reconciliation
  • Perform blinded data review checks
  • Completion of database lock activities
  • Complete dry run of Tables, Listings and Figures (TLFs)
  • Generate data sets and publish it for final analysis
  • Database Lock & Archive

Clinical Data Management Technology

We have supported clients to execute clinical data management on the following Electronic Data Capture and Medical Coding systems:

  • Oracle Inform, Oracle Clinical, Remote Data Capture, Thesaurus Management System
  • Medidata Rave, ClinSpark for Early Phase Clinical Trials

Additionally, we provide a 24/7 EDC Helpdesk to support Site Investigators and other system users.

Team Discussion


Techsol’s fully-managed ready-to-use CDM and Medical Coding Platform for emerging biopharma.

Oracle CDA

Obtain comprehensive insights on clinical programs, trial progress, site performance and data quality.

Compier PMS

Design, Conduct and Manage Post-Marketing Surveillance Studies across Therapeutic Areas.

New Insights

How to Proactively Prevent Clinical Trial Protocol Deviations and Protocol Violations

Understanding the Importance of a Clinical Trial Protocol The fundamental objective of a clinical trial protocol is to provide common scientific guidance on how to conduct the clinical study in a regulatory-compliant manner and gather data that will ultimately provide answers on the safety and efficacy of the investigational medicinal product. The Guidelines for Good [...]

Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials

What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]

Best Practices for Signal Management in Pharmacovigilance

Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]

Let Us Know How We Can Help You