Integrated Platforms & Applications
- Integration across all eClinical suite
- User interface to integrated common data points across eClinical suite
- Capturing integrated data discrepancies
- Live data transactions across eClinical suite
- Single entry for common data points
- Single sign on
- Easy reconciliation
- Limitless integration
Technology Innovations & Data Services to accelerate Drug Development
- Partnership with Microsoft technologies
- R&D centre for Artificial Intelligence implementation in Healthcare industry
- Multi device compatibility for all application
- Web based applications by using Agile methodologies
- Using updated technologies or framework on both database driven and user interface to reduce end user buffering and data transaction time
- Cloud Hosting at low cost maintenance for clients
- Maintaining data securities and customized data back ups
- Testing and validated applications
Regulatory & Compliance
- 21 CFR Part 11
- We are in compliance with 21 CFR Part 11 by maintaining System generated Audit Trials, Authentication, Authorization. Training the people who work with the system or develop the same system. Prevention of falsification.
Password security, e signatures, Validate the applications for IQ, OQ and PQ.
- Password change in defined intervals and formats. Keeping patient data safe. To penalise those who do not comply with confidentiality regulations. Encrypt sensitive files that are sent through emails. Protect the network from hackers. Prevent data entry mistakes by using double keying, checksum and other redundancies techniques.
- Patient safety, product quality and data integrity. Quality by design. Continuous improvement within QMS. Configurable systems and development models. Affective supplier relationships. Use of existing documentation and knowledge. Science based quality risk management system. Life cycle approach within QMS.
- Clinical trials should be conducted in accordance wit the ethical principles, consistent with GCP and applicable regulatory requirements. The rights, safety and well being of the trial subjects are the most important considerations and should prevail over interests of science and society. Each individual involved in conducting a trial should be qualified by education, training and experience to perform his respective task. The confidentiaty of records that could identify patients should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements. Systems with procedures that assure the quality of every aspect of the trila should be implemented.
Best of Breed Vendor Solutions
- Software as a Service – delivery model in which software is licensed on a subscription basis and is centrally hosted
- Multitenant Architecture
- Easy Customization
- Better Access
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