Clinical Data Management has certainly evolved over the years to reflect the changing clinical trials landscape. Pharmaceutical, biotechnology and medical device companies rely on various outsourcing methods to carry out data management activities such as putting a Functional Service Provider (FSP) team in place for product-specific work, outsourcing to low-cost countries or centralizing biometrics to ensure quality and traceability. With the advancement of technology, there are also various data collection, reporting and visualization systems to consider. Sponsors need to find cost-effective ways to manage vast amounts of data in a traceable and transparent way.
The key to any successful project is effective planning. Due to increased requirements by regulatory authorities and new legislation, such as the EMA’s upcoming clinical data transparency law, the Clinical Data Manager has more of a stake in the requirements for data collection, data accurary and data quality.
Moreover, when it comes to your clinical data management activities, how do you evaluate quality vs cost? CROS NT discusses cost reduction strategies for clinical data management that still ensure top quality clinical data.
Consulting a CRO with Global Libraries. The use of a Global Library can significantly reduce DM costs by re-using forms – cost reductions of up to 50% if implementing the centralized biometrics outsourcing model. In EDC studies, Sponsors can save 40-45% on second and subsequent studies in database setup, reuse of forms from the library and training costs.
This method guarantees a uniform traceability of data, better preparation for the EMA’s transparency initiative, due diligence ready datasets and documentation and one single Project Manager.
CDISC Implementation. Adopting and implementing CDISC standards can increase drug development analysis costs. However, identifying the right process for implementation and choosing the appropriate technology can reduce the costs of adopting these standards, making it a very worthwhile investment in the medium to long run. Conversion to CDISC standards generally includes SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model) and CDASH (Clinical Data Acquisition Standards Harmonization).
It is important to start implementing CDISC standards during data collection by having Data Managers design the CRF using CDASH standards. This makes the process of mapping data into SDTM and ADaM datasets much more straightforward.
Consult your Data Manager on EDC. eCRF significantly reduces the time and costs for certain stages of a clinical study. Direct and indirect costs can be reduced thanks to parallel operations during the use of a centralized database that can be accessed simultaneously by many people using the Internet. The availability of cost-effective, open source or proprietary EDC applications for individual physicians/researchers, departments and institutions has the potential to improve clinical and research activities. Cost is an important, if not the most important, factor to be considered while choosing an EDC system. Although the nature of licensing and support required to maintain EDC systems are the main predictors of cost, data capture and workflow at the site implementation also have a major influence.
Introducing FSP 2.0 – If the FSP model is your outsourcing method of choice, consider a new and improved model that deals with negative effects regarding staff retention and dedication. CROS NT’s “next-generation FSP” solution can put together a DM team that controls costs by significantly lowering staff turnover, guaranteeing coverage of sick days and holidays and eliminating the “silo” effect.
If you’d like to evaluate your upcoming data management needs, schedule a meeting with CROS NT to decide which outsourcing strategy is best and how we can reduce DM costs. CROS NT has over 20 years of clinical data management experience, managing more than 1,000 studies with resources worldwide. We are also a CDISC Gold Member and can consult on the implementation of these data standards.