Case Study 4: A Full Data Management Solution
- Details
- Written by Anayansi Van Der Berg
- Category: Case Studies
Working in a Collaborative Environment
The Scenario:
A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable.
RA eClinica Solution:
- RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics and Programming.
- RA eClinica preferred Data Management systems utilized with Sponsor's Safety Surveillance system and Clinical Trial Management System, CTMS
Ra eClinica Results:
- Study ongoing - All deadlines to date have been met or exceeded
- Cost savings of approximately 35% in comparison to traditional CRO models
- No turnover since study start
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
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Case Study 3: Out-of-Box Solution
- Details
- Written by Anayansi Van Der Berg
- Category: Case Studies
The Scenario:
The Sponsor required a solution to effectively manage and control users (internal and external).
RA eClinica Solution:
- RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
- Develop, deploy and host the clinical documentation service and provide customer support.
Ra eClinica Results:
- Development of an electronic tool to manage the program and provide ongoing operational management support..
- Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
- Reports are XML-tagged for further integration with in-house systems and third party service providers,
- Integrated Help desk support system
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
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Case Study 1: Stand Alone Satellite Office Solution
- Details
- Written by Anayansi Van Der Berg
- Category: Case Studies
Integrated Into Sponsor's Clinical Data Management (CDM) Environment
The Scenario:
The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor's CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resources on-site was not an option.
RA eClinica Solution:
- RA eClinica Data Management Operations collaborated with Sponsor to develop CDM metrics, collaboration model and workflow, enabling the team to work across 3+ protocols
- RA eClinica provided a full solution of 5+ CDM resources, project management, dedicated secure facilities integrating into Sponsor's eClinical and CDMS databases.
Ra eClinica Results:
- Develop of a long-term, efficient and cost-effective CDM solution.
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
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Case Study 2: Supporting the Sponsor with Database Transfer Solution
- Details
- Written by Anayansi Van Der Berg
- Category: Case Studies
Assisting the Sponsor with Database Transfer Solution
The Scenario:
The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:
- RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
- RA eClinica collaborated with the Sponsor's safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
- Ra eClinica team is responsible for managing over 5+ compounds
Ra eClinica Results:
- RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
- RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
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The Goals of Global Clinical Data Management
- Details
- Written by Anayansi Van Der Berg
- Category: Clinical Data Management
One of the challenge pharmaceutical and biotech companies faced today within their Clinical Data Management is the rapid changes and improvements in data management/capture technology.
Electronic Data Capture tools such as Oracle InForm and Medidata Rave allow for obtaining large sample sizes with reduced unit costs through global access, fast interaction, and automation. They provide a fast and easy avenue for the acquisition of scientific data, and this method of data acquisition will become much more common place in future multi-center clinical trials.
The implementation of EDC system eliminates the need for double-key data entry as the system automatically checks for inconsistent, illogical or missing data. In EDC, most of the data management planning and implementation are completed even before data entry is initiated. The annotated CRF, database design, and the vast majority of edit and logic checks are finalized prior to enrolling the first subject. The CDM can now look at the data in real-time, and begin the generation of data listings and identification of potential problems early during the course of a study. Training for CDMs in this new global environment, must accommodate this change in technology and shift in the clinical data management paradigm.
THE GOALS OF GLOBAL CLINICAL DATA MANAGEMENT
- Provide Electronic Translation Solutions: Developing translation software to transform data reliably from a variety of sources into a standard readable format.
- Develop Data Management Standard Operating Procedures (SOPs): Following Good Clinical Practices (GCP), and GCDMP in a standard way on a global scale.
- Verify Data for Protocol Compliance: Global standards in assessment of all image and non-image data to ensure proper display format, data integrity and conformance to protocol in accordance with FDA (and/or other) regulations.
- Develop Global Standards in Archiving of Original Data & Back-ups: Provide archive solutions based on the size and type of data sets involved in the trial and the sponsor’s needs. Utilization of a secure on-site data storage facility to house electronic backups of all trial data in compliance with GCP disaster recovery requirements.
- Track Patients and Workflows: Training of Research Associates to electronically monitor all trial data workflows. Providing the sponsor with access to this workflow via a secure link (web interface).
- Provide Sponsor with Electronic Access to Database: Providing sponsors with access to trial data via a secure link (web interface).
- Create Database of Data Analysis Results: Extraction of trial data and submission of it in sponsor-specific database formats.
- Digital FDA Submission: Digital databases of images, reports, and analysis should be suited to be submitted electronically (digitally) to the FDA (and/or other regulatory agencies).
- Timely Transfer of Data to Sponsor.
Reference:
Allan, Nick: Training for a Global Clinical Data Management Environment (2007)
Our certified Medidata Rave consultants and trained InForm staff will be able to provide and support EDC development from project planning through database lock whether on-site or offsite.
Not only we can provide training but we are committed to delivering quality service to your organization or CDM department.
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.
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