Pharmaceutical and biotechnology sectors are at the forefront of the technology use since their infancy. These companies are constantly in the requirement for innovative tools that are cost-effective, easy-to-use, intuitive, and compliant to regulatory requirements. Moreover, these technologies have been making strides in the industry, where use of the software makes the time consuming tasks much quicker and easier. Clinical data management forms an important part of the clinical trial process. It helps in assisting clinical research professionals in managing, collecting, and collating the study data of all the reports. They also help in assisting the sites in gathering the trial specific information, track study performance, planning, scheduling and well-informed decision making. Scalability and flexibility software is the requirement of the industry for performing clinical trial operations, therefore enabling the organizations to manage and collaborate with its units or within the partners. The tools have the capability to perform critical tasks such as planning, reporting, storage of participant contact data, manage clinical trials, and tracking milestones and deadlines.
Most of the medical research institutes, organizations, research centers managed by the hospitals use these clinical data management software. These software helps the healthcare companies to improve and enhance the quality of the products, ensure compliance with industry specific regulations, and optimize their times to market. This software is majorly used by the researchers to define, track, and implement the results of clinical trials. Administrative personnel of clinical trials also use this type of application to find and schedule participants, and track their involvement in the trials. The implementation of a Clinical Data Management System tool within an organization is an significant milestone as it involves different aspects such as financial, processes, resources, and regulatory. However, some of the disadvantages of using these software are financial issues, temporary loss of productivity associated with software adoption, changes in workflow, several unintended consequences, and privacy and security concerns.
Most of the business challenges faced by the pharmaceutical and biotechnology sector are as follows:
- Collecting, planning, managing and collating of study information.
- Tracking, scheduling, decision making of all the related tasks to clinical trials management.
- Scalability and flexibility to handle large amount of data.
- Compliance to industry regulations.
- Processing of redundant data.
- Rising investments and costs.
- Shorter go-to-market timelines.
- Increasing productivity both internally and externally
All these can be solved by the use of the clinical data management software’s. Most of the popular software used by the institutes, research centers, and organizations are as follows:
- IBM Clinical Development
- Edge CTMS
- MasterControl CQMS
- EXPeRT eClinical
- BioClinica CTMS
- Ofni Clinical
- Clinical Research IO
- LifeSphere CTMS
- Allegro CTMS
- OnCore Enterprise Research
- Castor EDC
- Clinical Conductor CTMS
- BSI CTMS
- Target Health
- Clinical Studio
Top features that one looks for in a CDMS and how they can give clinical trials that much-needed boost are as follows:
- Investigator Performance
- Site Communication
- Mobile Optimization
- Cloud Deployment
- Managing Resources