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

AccelClinical

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

4 Effective Strategies to Accelerate Site Selection to Activation

Introduction to the site selection process Clinical research organizations (CRO) predominantly rely on the internal networks and investigator database to support a clinical study for a drug. As the clinical sphere continues to expand at a rapid pace, there is an upsurge in demand for clinical trial sites worldwide. CROs are striving for new sites […]

Aggregate Reporting – Significance, Classification and Challenges

Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive [...]

Literature Screening – Process overview, challenges en-route and the scope for automation

Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug. The scientific […]

Let Us Know How We Can Help You