Data Acquisition

CONVINCED ELECTRONIC DATA CAPTURE IS A COMMODITY? THINK AGAIN!

But if all you’re talking about is entering clinical data into a structured, validated electronic database we would probably agree. But “Data Entry” is a small, simple part of Data Acquisition. Today’s clinical research industry is facing unprecedented new challenges. Trial designs are substantially more complex while at the same time clinical schedules and budgets are compressed. Researchers need to analyze large volumes of data to detect signals and trends in safety and efficacy. On top of this, collaboration among partners, data exchange with external sources and electronic submission to regulatory agencies demand standardization and compliance. Traditional manual and function-specific system approaches can no longer satisfy evolving research and development needs.

EDETEK’s Panther CTMP™ 3.0, is the most cost effective, unified Clinical Trial Management Platform available providing end-to-end management and insight into all aspects of clinical study conduct. But software doesn’t run clinical studies, people do. Our experienced clinical team coupled with the best platform does it the best!

Our fully adaptable tools and processes allow you to optimize rather than compromise your protocol.

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CLINICAL DATA MANAGEMENT SYSTEM

Enables the transformation of study protocol to CRF Design and EDC setup. Includes medical coding and extensive metric dashboards and structure based on CDISC or sponsor’s standards.

PATIENT MANAGEMENT

Provides patient registration, study calendar setup, and activity tracking functionalities.

SITE MANAGEMENT

Provides site registration, investigator and site document management, study team communication and monitor management supporting risk based and remote monitoring capabilities.

RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT

Provides patient randomization and recruitment, trial supply management, drug dispensing/reconciliation and controlled un-blinding functionalities.

eTMF (ELECTRONIC TRIAL MASTER FILE)

Enables centralized management of electronic study documents, including versioning, workflow, and audit trials

CDW (CLINICAL DATA WAREHOUSING)

Provides centralized storage of program level clinical data, as well as all associated metadata. It enables the use of platform visualization tools across all study stages.

MEDICAL SAFETY REPORTING SYSTEM

Supports adverse event notification, management and reporting.

REGULATORY SUBMISSION

Supports medical writing, Clinical Study Report development, and eCTD based submission.

TRANSFORMATION & ANALYSIS ENGINE

Provides metadata driven data conversion, standardization, derivation, statistical analysis, and TLF development. Supports CDSIC standards, such as SDTM, ADaM, and Define.xml.

EXCHANGE CONNECTOR

Provides data and metadata exchange interfaces to external systems – Labs, ePRO, Imaging, EHR, etc. Supports HL7 V3, XML, SAS, CSV, etc.

UA PORTAL (UNIVERSAL ACCESS PORTAL)

Provides unified access to entire Panther CTMP™ 3.0 suite, with interface for set-up, optimization, management, monitoring, reporting, and administrative functionalities.