Clinical data management is a challenging task in the existing regulatory scenario. As the research and development costs are increasing every day, with many patents expiring and requirements for approval of new drugs by FDA, it is quite conclusive that the costs need to be reduced and also a reduction in time for marketing the product.
Training for data management of clinical data is quite a challenge in itself. As it is regarded by many to be one of the most important and valuable assets of any organization, the data management should be practiced in a more responsible manner with an efficient management system. Inconsistent management practices, management of data in a poor fashion, adopting outdated technology and not utilizing the available data can hold the growth of the company and result in a negative behavior of the company.
As the information stored in an organization's database helps in providing the required knowledge in undertaking decisions, managing projects, and keeping it moving forward, it is quite critical to understand those data, using the right tools to utilize its potential and making sure that the man-power and staff possess the right training in bringing out the best from it.
The services offered in the field of clinical data management integrate clinical data expertise and technology, ably supported by a quality framework that enables in delivering great quality data every single time.
The services include data migration, database programming and design, data loading, data entry, laboratory data management, data review, pCRF/eCRF design, medical dictionary coding, database lock, scanning and indexing, SAE ( Serious Adverse Effects) Reconciliation etc.
It also includes varied services such as CDM project management, CRF Annotation, data management plan, handling of external data, CRF completion guidelines, medical coding, entry and verification of data, quality assurance and validation of clinical data, interim and final transfer of data, filing and archiving.
Training for data management helps:
·To establish and protect intellectual and proprietary rights
·Helps in providing estimate of cost for management and production of digital data
·Developing metadata for each product
·Develop and protect the data bank
·In translating the data to data management tools
·Providing training to decision-makers which empowers them to identify effectively and use the data information in a more proper way
·It provides in giving an information plan, the operations' concept and the enterprise's data strategy.
Role of clinical data management