The cost and time effective conduct of clinical trials is possible by using digital tools. It is very difficult to organize huge amounts of data on paper. Further digitization can reduce manual errors enormously and no requirement for physical storage of documents which ultimately lead to cost and time effective clinical trials. The paperless trials increase the compliance with audit trails and also speed of trials. Electronic documents are going to be an accepted mode of submission to regulatory authorities in future.
Auriga Research has come up with complete digital solutions to clinical trials by using tools like CTMS, eTMF, eISF, rSDV, TMS, QMS, EDC. The advantage of working with us will be complete training and implementation by our team along with data collection from the sites & complete QA/QC processing. The data collected from these tools is 21 CFR Part 11, GDP, HIPPA and CDISC compliant and provisioned to be submitted anywhere in the world. We also provide access to these tools to the Sponsor for online monitoring of progress of their studies and it can be accessed from anywhere in the world as data is hosted on cloud servers.
OneClinicalTrial Platform
The OneClinicalTrial Platform is an Integrated Digital Clinical Trial Platform which enables Sponsors, CROs, and Research Sites work collaboratively and manage all aspects of clinical trials effectively in one place
Master Data Management (MDM)
Clinevo Master data management (MDM) is a cloud-based Master Data Management software to manage Sites, Investigators and other clinical trial information in a centralized means to ensure the uniformity
Clinical Trial Management System (CTMS)
Clinevo Clinical Trial Management System (CTMS) is a cloud based, highly configurable, end-to-end platform which helps manage all aspects of clinical trials.
Electronic Trial Master File (eTMF)
Clinevo electronic Trial Master File (eTMF) is an easy to use electronic trial master file in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.
Electronic Investigator Site File (eISF)
Clinevo electronic Investigator Site File (eISF) is a cloud based, easy-to-use and highly secured electronic document management platform for investigator sites involved in the clinical trial for full control over their investigator site files (ISF)
Electronic Data Capture (EDC) / eCRF
Clinevo EDC/eCRF is a cloud based, easy to use, regulatory Compliant, end to end Electronic Data Capture (EDC) / eCRF system
Remote Monitoring | rSDV (r-SDV)
Clinevo Clinical Trial Remote Monitoring System(rMS) is a web based & easy-to-use software which enables companies to perform remote Source Data Verification (rSDV) / remote Source Data Review (rSDR) without having monitors travelling to the sites.
Metadata Repository (MDR)
Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end-to-end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform.
Pharmacovigilance Database
Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end-to-end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform.
One Quality Management System (OneQMS)
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. OneQMS enables organizations to manage documents, training.
Training Management System / eLearn
Clinevo Training management system/eLearn is a cloud based, regulatory compliant training management system for managing and maintaining training records digitally.
Clinevo Document Management System (DMS)
Clinevo Document Management System is a web based easy-to-use document management system to maintain, review, approve, manage, publish your organization’s documents.
With the complete electronic system, we can connect all clinical trial stakeholders for seamless information sharing can collaborating in real-time on a single document management platform helps us tackle study tasks faster and keep research
- Automate study start-up processes through task automation.
- Strengthen compliance by automating tracking, alerts, and readiness indicators..
- Improve patient safety by providing real-time alerts and protocol information.
- Automate the source to EDC connection to reduce repetitive tasks and accelerate data analysis.
- Reduce site-selection dropouts by providing deeper visibility into site selection processes.
- The CTMS System works as a single point of access for trial related activities.
Digital Tools helps in achieving the study goals
- Very easy to visualize the subject enrolment and take necessary action accordingly
- It brings entire functional team at one platform to resolve any issue quickly
- Sometimes it reduces number of protocol amendments
- Improve Audit Experiences, Reduces Human Errors, and Reduces Manual Process through maximum electronic records and digitalization.
- Integrate and standardize trials data from different sources into unified data repository to ensure that virtual information is accessible to all stakeholders anytime anywhere
- Reduce overall cost and time spent on clinical trials
- Increase operational efficiency and excellence wit real-time collaboration
Remote access to study sites currently requires sponsors to log into dozens of different platforms across hundreds of study sites. The one clinic integrated with the study site’s existing systems will provide a single access point for any sponsor/CRO. The electronic system is completely integrated with each other which reduces multiple time entry and work on single sign on to all the system
