Darsan Clinica offers CDM services with maximum flexibility. Sponsors may contract all or a portion of their CDM work load to Darsan. Our infrastructure and clearly defined system interfaces provide us the flexibility to define work processes between a sponsor system and our environment as well as seamless integration in to sponsor defined processes. Our systems & services are based on industry recognized standards and technology platforms to ensure that even the most challenging data management activities are efficiently and effectively addressed.

Darsan Clinica Life Sciences offers a complete range of clinical data management activities using one of the most powerful clinical data management systems: Oracle Clinical (O.C)

With over the years of system and user experience, our current data management version OC 4.5.3 is fully validated and 21 CFR Part 11 compliant. The following tasks are performed by Darsan Clinica using Oracle Clinical: Randomization, Database set-up,

Data entry, Medical coding (the Oracle TMS (Thesaurus Management System) version 4.5 is used for coding medical information initially entered in Oracle Clinical as verbatim terms. Different versions of dictionaries can be used to fulfill the sponsor's needs.

Coding specialists perform the coding in the standard and proprietary coding dictionaries MedDRA and WHODD), Discrepancy handling, Laboratory data handling and Data extract.

Darsan Differentiators in Clinical Data Management:

1. Qualified Database Programmers experienced in designing and implementing Clinical trial databases and data validation programs.
2. Coding specialists to assist coding in standard and proprietary coding dictionaries such as MedDRA, WHODD, and ICD-9-CM.
3. Specialists experienced in drafting CRFs and questionnaires.
4. Trained and experienced data entry specialists.