“The Life sciences industry expanded rapidly in the last few years. The global growth has been a result of the large scale research. Considering that health and well being are such a crucial part of our lives, it can safely be assumed that the contribution of health care industry to economies all over the globe is quite significant.”
In such a scenario, life sciences industry needs the cutting edge of technology and robust processes which help serve their mission by improving drug manufacturing, streamlining research and data management.
Increasing global competition requires health care companies to offer their services at prices that are falling rapidly. This makes optimization of the cost of operations a necessity.
CLINICAL STUDY BUILD SERVICES
- CRF design specifications (contents from protocol)
- CRF planning and approval meeting
- CRF screenshots and final CRFs development
- Generation of CRF completion instructions, self-evident correction and quality assurance error rate documents
- Database design, development, and validation
- Data Management Plan (DMP) and Data Validation Plan (DVP)
- Development, programming and validation of edit specification documents (CF and Edit Checks)
- Data back-up, archival, preparation of CRF CD for all sites and studies
- Diary reconciliation, central lab reconciliation & data transfers
- Development, programming and review of data review listings for clinician & statisticians
- Database Lock : final database freeze/closeout and locking activities
MEDIDATA RAVE COMPETENCY
Custom Functions
- Study build and development
- Edit Checks and Derivations
- Custom function programming
- Extracts development
- Develop and deploy configurable datasets
Custom Scripts
- Test Scripts creation
- Script issues execution
- Rave Data Extracts (RDE)
- Rave Web Services (RWS)
Custom Reports
- Business Objects Reports
- Crystal Reports development
- Validation plan and Summary reports
- Report issues execution
Custom Outputs
- SAS Datasets and Reports
- Clinical data extraction (Operational and Metadata)
Quality Control
- External data load
- Lab data and IVRS data
- Test execution/QA, UAT support
- Test data preparation
- Data quality reviews
WHAT MAKES PARADIGM UNIQUE
- Best-in-Breed partnerships over a decade
- Fortune Pharma and CRO Global Clientele
- Strong team of domain and industry experts
- Process excellence through ISO & CMMI Level 5 Standards
- Well-versed and skilled on various modules, such as;
| BU processing | Report administration |
| Standard reports | Lab administration |
| Site administration | Configuration module |
| User administration | Amendment manager |
PARADIGM LEVERAGE
- Best-in-Class Service Delivery and Processes
- Dedicated Client Emphasis
- Unrivaled off-shoring pricing structure
- Audit-ready Global Delivery Practices
- Predictable and Tangible Engagement Results
PARADIGM KEY STRENGTHS
- Privileged service and technical go-to partner for Medidata over a decade
- Clinical research and EDC capabilities of live data
- Assistance in SAS and other data reporting activities on demand
- Reduction in Clinical Development Costs with utmost quality and training of personnel on-site on Medidata Rave
- Assistance in development of complex edit checks with best practices
- Over 50 man years’ of experience in study build, edit checks, custom functions, eCRF development and other Rave integrations (RDE, Configurable Datasets, etc)
- Over 10+ years of experience in building for over 3000+ studies for various therapeutic areas and different phases on Medidata Rave
- Have provided services to Global Top 10 and Fortune 50 organizations
- Variety of roles operated and fulfilled in Rave services, like Designing, Developing, Programming, Testing, Validation, Data Management, and Technical Support