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Data Management Services

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

Biostatistics Services

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

Randomization Services

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:

Interim / Final Study Reports
ISS / ISE Manuscripts / Abstracts / Posters / Slides