Utilization of Technology Intelligence in your Clinical Research Program Leads to Improved ROI
Technology in Clinical Trial Services
About Our Service
Utilizing a host of clinical research applications, ParadigmIT offers an extensive collection of services for pharmaceutical, biotech, medical device, and life science companies. We provide customized, end-to-end clinical data management services as per the client’s need. ParadigmIT team consists of functional, technical and industry experts who can successfully assist pharma and life science companies in navigating the complexity of the clinical trial lifecycle. This expert consulting can be leveraged to identify the most suitable and most cost effective clinical operational and clinical data management technologies from the market.
❝Combining Clinical Trial Data with Advanced Business Technology Saves our Clients Time and Money.❞
Our Service Offerings
ParadigmIT has assessed multiple systems and understands the best-in-class applications/tools for your clinical trials. We confidently offer our clients the right technology solution according to the trial design requirements. Our focus is to provide:
1. Technology enabled tools to speed up the trial start-up process
2. Standardized eCRF development ready to map into respective SDTM domains
3. Unambiguous and quality data from sites through well designed eCRFs
4. Timely receipt of external vendor/third party data
5. Frequent review of safety and protocol end points data via BI tools
6. Insight to clinical operations and CDM teams on anticipated risks
7. Custom solutions to handle the live integrated data of eCOA/ePRO
Quality Control (Contracted and Non-contracted)
Clinical Data Management (CDM)
ParadigmIT offers, flexible engagement models through stand-alone, full service, or functional outsourcing in the following areas:
- Database build, testing, and deployment
• Case report form (eCRF) design and review
• Edit check development
• Programming complex checks as allowed by each of the EDC tools - Data entry (if needed), validation/verification
- Medical coding
- Safety and external data reconciliation
- Site/CRA EDC training (on demand)
- EDC user/site administration
- Database lock and study closure
- Database migration/rescue from legacy systems
- Integration of EDC with other clinical applications
- Study data archival
- Custom function development (specific to RAVE)
- Custom reporting and visualization development such as:
• Business Objects reports Crystal Reports development
• Spotfire business intelligence tools
• Power BI tools
• SAS/SQL based reporting
• Custom scripts (specific to RAVE): Coder scripts | SIS integrations | Diagnostic scripts - Custom data extracts and integrations:
• Scheduling SAS Jobs/SQL data extracts
• SDTM/ADAM
• Rave web services (RWS)/ODM extracts
Other Services
- Statistics Programming :
Our comprehensive biostatistics services encompass the following, ensuring your research and healthcare projects are driven by robust statistical methodologies for accurate results and compliance:
• Randomization
• Data analysis
• Clinical trial design, including sample size identification
• Statistical consulting
• Regulatory query support - Medical Writing
Our expert medical writing team ensures that your scientific and healthcare content is clear, concise, and compliant, facilitating effective communication in the ever-evolving field of medicine.
We provide the following services:• Investigator Brochures
• Protocols
• Clinical Study Reports
• Safety Reports – Narratives
• Manuscripts
Consulting for Clinical Trials
- CUSTOMIZED Solutions
- expertise
- Application development for pharma/life science companies to manage their routine tasks digitally to increase efficiency.
- Advanced technology adoption to manage the new complexities in clinical trial execution reducing drug development turnaround time.
- AL & ML powered Data Aggregation and Analysis to generate insight for the future drug development pipeline by:
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- Defining disease prevalence
- Identifying potential drug candidates
- Collecting and analyzing post-marketing safety assessments
- Compiling current market feedback on marketed products to initiate a more targeted approach to the R & D process for a new molecule.
- Randomization and Trial Supply Management (RTSM)
- Clinical Trial Management System (CTMS)
- Medical Imaging Systems
- Cloud Administration
- ePRO/eCOA
- Safety gateway/DB
- Targeted SDV support
- Batch Uploader
Excellence, Efficiency and Results
One of the key factors for a successful clinical study is
to have an experienced team who can confidently execute your clinical trial on time with utmost and high-quality deliverables.
- Team of industry experts and clinical professionals
- CDM “Full Service” support on all major EDC platforms
- Experienced in multiple EDC Platforms on Study Build
- Cost effective solution due to the technology/solutions
- Disaster Recovery Planning and Execution
Our focus is on utmost data quality and cost effective processes in validating the trial data. We had designed and tested the automated data validation/cleaning process keeping in mind the ease of adoption and pocket friendly to Customers. From the day we learnt Pharma industry will see a Paradigm shift in conducting trials our research involving industry experts and well qualified technology architects also began.
The result of this brainstorming and research in the Clinical Trial conduct process involving multiple functional teams leading the ParadigmIT to be in the forefront.
- Reduction of Specification review and Study build TAT
- Improved Cognitive data insights generation using Business Intelligence tools
- Reduction in data cleaning/validating TAT Improved KPI of LPLV to DBL
- Recommendation of enhancing the EDC Platform and Clinical Tools based on our Technology DNA