Generating High Quality, Reliable and Statistically Sound Clinical Trial Data
Techsol provides centralized clinical data management services for Phase I to Phase IV clinical studies across various therapeutic areas with a comprehensive risk-based data management plan. We work with sponsors as an extended partner to generate high quality, reliable and statistically sound clinical trial data using industry-leading electronic data capture (EDC) technologies.
Why Sponsors Choose Us
- Team members with over 15+ years experience
- Certified and Audited Quality Processes & SOPs
- Delivered with integrated and validated EDC & RTSM Platform
- CDM Expertise for different Therapeutic Areas
- Availability of Real-time Study Metrics and Dashboards
- Experienced in conducting Investigator Meetings
- EDC Technology offered with 24x7 EDC Helpdesk
- Proactive Risk management & Mitigation plans
Our Clinical Data Management Services
At Techsol, our expert team of Clinical Data Management Professionals have an extensive research background, scientific knowledge, and ample experience in generating scientific evidence to account for safety and efficacy across clinical development programs for global pharma companies.
We provide end-to-end clinical data management support starting from eCRF design to database lock and final study archival with 100% compliance to 21 CFR part 11, GAMP 5 and HIPAA requirements. To ensure data quality and deliver value, we offer our expertise in the below mentioned areas throughout the clinical data management lifecycle.
Phase I to Phase IV Clinical Study Data Management
We provide end-to-end data management services for all types of Phase I to Phase IV clinical studies across therapeutic areas. The below table outlines our comprehensive set of CDM activities and deliverables for every project we undertake from a client.
Study Data Management Planning
- Study Protocol Review & Study Data Needs Assessment
- Data Management Plan Preparation
- Case Report Form (CRF) Development
- eCRF Filling Instructions
- Patient Diary Design
- Data Validation Plan Preparation
- Data Quality Oversight Plan
- External Data Handling Guidelines & Data Transfer Specifications
- CDM Project Management Plan
EDC Study Database Setup
- CRF Annotation using CDASH standards
- Study Database build in EDC System
- IWRS Study Randomization System Integration with EDC
- Univariate and Multi-variate Edit Checks Programming
- Study Database User Acceptance Testing
- EDC System Access to Site & Study Personnel
- EDC System Training to CRAs, Principal Investigators and Site Personnel
- External data loading setup
- Data extraction setup
Data Validation & Quality Management
- Site Data Entry Oversight
- Continuous Data cleaning from FPFV to LPLV
- Source Data Verification & Risk-based Monitoring
- External Data Loading
- Labs, ECG, Patient Diary, IRT data, images, ePRO/eCOA
- Query Resolution Management
- Query Aging
- Ongoing Data Quality Control
- Medical Coding (MedDRA, WHO-Drug, SnoMed, etc.)
- Post-production Study Database Changes
- SAE & External Data Reconciliation
- Data Listing Transfer & Review
- DM Metrics & Status reports
Study Data Extraction & DB Lock
- Resolve all Outstanding Queries across Sites, CRAs, and DM Review
- Complete approved eCRF data updates for irresolvable data queries
- 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
Benefits We Promise
Study Startup
> Smart CRF Design as per Study Protocol for comprehensive data collection without redundancy
> Flexible EDC System Choices with integrated Medical Coding for Rapid Study Database Setup
> Hands-on Training to Investigators & Site Personnel to ensure consistent High Quality Data Capture
Study Conduct
> Support for Targeted Source Data Verification that is aligned to Risk-based Trial Monitoring
> Seamless External Data Import & Reconciliation (Labs, eSource, eCOA / ePRO, Patient Diaries, etc.)
> Rapid rollout of Mid-study Changes with minimal disruption to ongoing study data collection
Study Close-out
> Robust Query Generation Alerts & Reminders that allows Faster Query Resolution across Sites
> Continuous Collaboration with Sponsor Teams for Data Quality Review & Interim Analysis
> Reduced time to Study Database Lock & Freeze with proactive closure of data validation activities
Data Processing
> Leverage Advanced DM Reports & interactive Dashboards to gain Safety & Efficacy insights
> Readily available pre-programmed SAS Macros for Tables, Listings & Figures Preparation
> Team is experienced with CDISC SDTM / AdAM dataset generation for completing e-Submissions
Service FAQs
There are two types of service models that your company can choose from:
Data Management FSP Model: Our team will take the responsibility of managing all clinical data management activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of Clinical Data Management needs for a fixed duration.
Through our strategic partnerships, we use the best of integrated EDC, RTSM, eConsent and Medical coding technology platforms that helps us to deliver our clincial data management services through continous real-time collaboration with sponsors.
Following are some of the systems we use:
> Oracle Clinical One
> Clinion EDC
> Oracle Inform
> Oracle Clinical, RDC & TMS
With the use of advanced technology and quality-driven processes, our data management team follow industry best practices to ensure accurate clinical data capture across sites. Our “Continous Data Cleaning Framework” is an integral part of our processes and it starts from First Patient First Visit (FPFV) to the Last Patient Last Visit (LPLV) until database lock and freeze.
