Clinical Trial & Clinical Data Management
WorkSure® Clinical Trial & Clinical Data Management Services can be a game-changing technology that can boost patient engagement and optimize clinical trial metrics, thus assuring clinical trial success. WorkSure® provides clinical research insights and support throughout all stages of clinical research, from Phase I to Phase IV by coordinating with the investigators, site employees, and patients. Its clinical operation services include clinical trial feasibility, site selection, clinical monitoring (including remote monitoring and risk-based monitoring), contract negotiation and execution with clinical sites, checking and evaluating case report forms, and clinical data monitoring. Apart from these, the company offers specialized services for clinical data management (CDM) such as strategizing and developing CDM plans, data extraction for analysis, and final reporting with supportive statistical and medical writing services.
We believe in cost-efficient, process-driven, time-bound, and knowledge-based data management systems. WorkSure® incorporates CDM System and provides a user-friendly, low-cost, integrated, customized technology-driven interface that ensures efficient and quick delivery of clinical processes. Our use of technology expedites the clinical development process, adherence to Good Clinical Practice and other regulatory laws with round-the-clock support allowing biopharmaceutical and medical device companies to market the products effectively in the multifaceted business and regulatory environment.
Our comprehensive clinical trial and CDM services enable our clients to reconsider traditional methods of CDM by redefining their clinical trial process, allowing them to achieve new levels of competency and efficiency. We offer flexible solutions to meet the analysis and management of data without compromising its integrity and accuracy. The company collects and handles all forms of source data, embraces decentralized approaches, and also provides easy data tracking back to the source to relieve data accessibility, integrity, and visibility difficulties. WorkSure® assures the highest quality and rapid data collection and distribution to stakeholders; superior data traceability; and a robust Quality Control System at database lock.
Qualities that differentiate WorkSure® Clinical Trial and CDM services:
- Excellent coordination among Clinical Research Associates (CRAs), product managers, investigators, etc. through skilled and experienced CDM staff
- Conversion of the study protocol into an efficient study endpoint, with accurate data capture and management
- Rapid resolution of queries and inconsistencies in compliance with the regulatory guidelines and trial requirements
- Faster study setups through a better approach and through leveraging in-house CDM library
- Robust and secure database to meet rigid timelines
WorkSure® Clinical Trial and CDM Services
Clinical Trial Management
- Lifecycle Support for Phase I to IV Clinical Research
- Clinical Development Strategy and Services
- Clinical Site Selection/Feasibility
- Preparation of Clinical Trial Agreement, Trial Master File (TMF)
- Clinical Trial Management System (CTMS) Support
- Clinical Research Site Initiation, Activation, and Close-out
- Clinical Trial Conduct and Monitoring
- Compliance Tracking
- Postmarketing Surveillance
Clinical Data Management
- Development of Data Management and Validation Plan
- Case report form (CRF) Screen Design
- Online and Offline Database Development
- Edit Check Creation
- CRF Tracking and Annotation
- Data Collection and Data Entry
- Data Validation and Discrepancy/Query Management
- Medical Coding and Data Reconciliation
- Database Locking and Unlocking
- Data Extraction and Archival
- Access Control and Data Security
- Data Analytics