MDS Bio-Analytics is primarily involved in statistical and bioinformatics services in clinical research and genomics domain to clients from biotechnology and pharmaceutical industry. In addition, we are supporting medical professionals and academicians from private / government medical institutes in their observational research through data analysis. The group is led by experienced professionals with expertise in biostatistics and programming.


Now we are also into Clinical Data Management (CDM) services through using our state of the art infrastructure. Besides, we have our professional partner engaged in providing regulatory and site management support. So operations, data management and biostatistics & programming - thereby offering a perfect synchronization of these three core segments of clinical trials.

Clinical Data Management

Randomized controlled trials are the gold standard for evaluating the safety and efficacy of novel therapy. We provide services on Clinical Data Management following 21 CRF Part 11 guidelines and Biostatistics & Programming. The support spans over phase I to IV studies in different therapeutic areas and primarily covers:
            ● Preparation of data management plan
            ● CRF and eCRF design
            ● Customized data base design
            ● Edit check programming and User Acceptance Testing (UAT)
            ● Validation check and query management
            ● Web-based data capture in a secured environment
            ● Electronic patient diary handling and integration with eCRF
            ● Serious adverse event reconciliation
            ● Data quality control
            ● Status tracking and reporting
            ● Data base lock and data export
            ● Archival of data

Biostatistics and Programming

            ● Regulatory statistical consulting
            ● Study design
            ● Sample size estimation
            ● Randomization scheduling
            ● Statistical analysis plan
            ● Statistical programming
            ● Interim analysis support
            ● Generation of tables, listing and figures
            ● Provide complete support in CSR, ISS/ISE preparations

contact us

Ardent Clinical Research Services

Office No. 318, level 3, Next to frankfinn,

Connaught Place, Bund Garden Road,

Pune-411 001, Maharashtra, India


MDS Bio-Analytics Pvt. Ltd.

Plot No. 127, Sakar Enclave,

First floor, Shankar Nagar,

Nagpur - 440 010, Maharashtra, India

Phone:+91 712 6617143 / 2245989