Actelion Pharmaceuticals Ltd and Ethical eClinical Solutions
Actelion Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, focusing on the discovery, development and commercialization of innovative treatments to serve high unmet medical needs.
Computer Assisted Data Processing (C.A.D.P.) System
Actelion Ltd has been using the C.A.D.P. (Computer Assisted Data Processing) web-based system for several years to manage Data & Project management activities.
Based on the Oracle DB, the system has been entirely developed by E-CRF staff in close collaboration with the Actelion Data Management and System Development staff.
Specifically, the Actelion Data Management division uses the system to track and enter data for dozens of studies per year.
The activated modules include advanced functionalities for data management:
- TRACKING: the management of research projects and respective associated users
- DATA ENTRY: the entry and editing of acquired data
- QUERIES: the generation and management of data inquiries (Data Clarification Forms), after Data Cleaning and Management procedures
- DPP MANAGEMENT: Digital Pen & Paper collection of forms
- DATA VIEW: the tool to browse clinical data and medical information (images, texts, and documents) available to accounts activated for data browsing, sharing and reviewing
- DICTIONARIES:module for clinical coding of verbatim terms according to international medical dictionaries (MedDRA, WHO) or to internal predefined project specific terminology
- RECONCILIATION: tool to manage interactive reconciliation of Serious Adverse Events
- LABORATORY: the management of medical analyses and visits
- NARRATIVES: tool for Narrative writing on pre-defined sets of clinical events
- DATA REVIEW: the periodical data revision with a chance to generate Data Clarification Forms
- PROTOCOL VIOLATION: the management of protocol violations/protocol deviations
- USER: the customization of a profile or account
- ADMIN: the general system administration
- REQUEST NEW ROLE: the management of access requests
- ACTIVATION REQUEST: the access request for a new online account
Endpoint ADJUDICATION System
eAdjudication has been used by Actelion Pharmaceutical for:
- Events submission;
- Review by the CEC Committee members in a centralized environment;
- Independent online adjudication of the cases.
This system represents an important instrument for the key phase in clinical trials, the clinical event management.
Clinical trials many times are driven by the events, and there are no clear standards for their definition and management, thus often leading to interpretations and possible bias.
Input from different data collecting systems are reviewed by a central committee (Clinical Event Committee - CEC) made of experts that decide if the received clinical data can be submitted as valid "cases" for the running clinical trial: Among the used data collecting systems, there are:
- Interactive Voice Response Services;
- Electronic CRF (Clinical Report Forms);
- Clinical data from Digital Pen & Paper technology ;
- Adverse Events database;
- Clinical Images data (ECG, radiology, etc...);
- Data Clarification Forms database;
- and more databases...
For every specific clinical trial the process plans review sessions.
The online Adjudication allows a real time tracking of the review phases and the case submission to the statistical analysis.
The benefit from a web based management of such volume and complexity of data is:
- Reduced Time to confirm;
- Tracking of every single review decision;
- Independent decision processes;
- Management of huge quantity of data involved;
- Management and tracking of data changing;
- Interactive tools such as generate Charts, view Radiology / CT images with zoom / measure / contrast features...
All these functionalities have beeen integrated into the C.A.D.P. platform (Computer Aided Data Processing) developed by E-CRF and used by Actelion Pharmaceuticals Ltd for its Data and Project management of the Clinical Trials lead by the company every year.
SMADAR Clinical Trial Registry
Study MetA DAta Registry (SMADAR)
The Smadar web-site is designed to provide up to date information on new clinical studies and their results.
It is intended primarily to help patients, their caregivers and physicians find clinical trials that may be appropriate for them.
The SMADAR Registry is implemented to serve this goal, providing a reliable central repository for studies, with the benefits:
- reducing the time spend for collecting study information required for regulatory purposes
- increasing the quality of study information by collecting the same kind of information about the studies in compliance with the known regulatory requirements.
- eliminating the need to create separate repositories for studies in different phases.