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 BCDM 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 is a Gold Member of Clinical Data Interchange Standards Consortium (CDISC) and designs studies using these standards.

DP Clinical uses Oracle Clinical as the database system of choice for Clinical Data Management. Oracle Clinical is validated to be Part 11 compliant. Oracle Clinical consists of:

●	Oracle Clinical (OC) for paper based studies
●	Remote Data Capture (OC/RDC)
●	Thesaurus Management System (TMS)
●	Adverse Event Reporting System (AERS) for managing safety

Our Clinical Data Management services include:

●	Design of case report form or eCRF
●	Preparation of CRF or RDC guidelines
●	Data coding using MedDRA and WHO Drug
●	Prepare Data Management Plan
●	Design database
●	Conduct system 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.