DP Clinical, Inc.

Services & Capabilities

Clinical Data Management -Study planning, clinical data monitoring, data management, and biostatistics are the foundation for success in the drug approval process. DP Clinical builds upon this foundation with an excellent biostatistics and data management (BCDM) departments.

DP Clinical can provide you with an extensive array of CDMB skills for your projects. We have the ability to help you design your program from its inception, or we have the flexibility to work with your organization to strengthen programs that you already have underway.

DP Clinical uses 21 CFR Part 11 compliant software, Oracle as the software of choice for data management which consists of:

●	Oracle Clinical (OC) for paper based studies;
●	Remote Data Capture (RDC);
●	Thesaurus Management System (TMS) using MedDRA and WHO Drug
●	Adverse Event Reporting System (AERS) for managing safety

Our Clinical Data Management services include:

●	Design of case report form or eCRF
●	Preparation of CRF completion guidelines
●	Data coding using MedDRA and WHO Drug
●	Prepare Data Management Plan
●	Design database
●	Conduct database validation and provide documentation
●	Query management
●	Safety Management and SAE reconciliation

Our focus on quality in these critical areas has resulted in a very low query rate as audited by clients and external organizations.