Data Solutions provides a full range of high-quality data management services for phase I-IV clinical trials. By recruiting well-qualified personnel, and providing ongoing training, Data Solutions has built a staff of data management professionals that ensure the integrity of our clients' data. Data Solutions delivers high quality data fast.
Data management services include:
Case Report Form (CRF) Design Data Management Plan Development Data Validation Programming Data Entry / Data Tracking Data Validation and Query Resolution Medical Coding Quality Assurance / Quality Control Database Delivery / Integration
The right analysis is fundamental for the success of clinical study. Data Solutions has an excellent biostatistics team. Most of our statisticians hold a PhD in statistics or biostatistics. With the rich experience and cutting-edge statistical knowledge, Data Solutions provides full range high-standard biostatistics services for phase I-IV clinical trials. Statisticians at Data Solutions develop rigorous and customized analysis plans that reflect other relevant FDA approvals and ICH guidelines. In addition, our analysis plans allow our clients to bring out the best value of their products from post marketing studies. Statistical programmers at Data Solutions execute the analysis plan, producing high quality analysis tables / listings / figures for study report, submission or manuscript.
Biostatistics services include:
Protocol Development / Study Design / Sample Size Planning Randomization Planning and Implementation Analysis Plan Development Programming for Interim / Final Analysis ISS / ISE Preparation NDA Submission / Electronic Submission Regulatory and Advisory Meeting Support Meta Analysis / Exploratory Analysis / Data Mining Health Outcome / Marketing Research Statistical Reports / Scientific Manuscripts
Data Solutions generates randomization lists and executes randomization for our clients.
Randomization services include:
Generating / Managing Randomization List Generating / Distributing Treatment Allocation Emergency Codes Executing Central Randomization Unblinding Treatment Allocation Codes
Health Outcome / Marketing Research Services
Data Solutions provides expertise for a broad range of health outcome researches that include:
Quality of Life (QoL) Assessment Work Productivities Evaluation Cost - Effectiveness Analysis
Medical Writing Services
Medical writers at Data Solutions provide high quality support to our clients at all stages of the drug development process. The services include writing:
Protocols Interim / Final Study Reports ISS / ISE Manuscripts / Abstracts / Posters / Slides