eClinical-DCT
eClinical-DCT
eClinical-DCT
Impakt eClinical suite is specially designed to fit to the Decentralized Clinical Trials (DCTs) a cutting-edge cloud-based solution built to capture clinical data at source and manage clinical data effectively throughout the clinical trial life cycle. Our innovative solution enables clinical research teams to efficiently collect, analyze, and manage clinical data of different complexity and size. Impakt eClinical-DCT is a scalable solution that meets all essential regulatory compliance requirements such as FDA – 21 CFR Part 11, GCP, GAMP5 and HIPAA.
Using Impakt eClinical-DCT, customers have eliminated 90% of paper-based processes, improved data quality by 80%, and reported a 37% reduction in overall process.
For each study , the effort spent by site on one patient can be reduced by 8 hours & the time spent in source data verification can be reduced by about 2 hours per patient. Since Impakt eClinical-DCT is an integrated platform, the solution offers a 65% increase in efficiency in managing overall clinical trial management at site.
Product Features
EASY STUDY SETUP
With the Impakt eClinical-DCT solution, set up and visualize studies according to protocol requirements and easily access details such as phase, type, therapeutic area, indication, outcomes, eligibility, and more
Patient Visits
The Impakt eClinical-DCT solution can define the procedures, subject visits & payment schedule depending on the budgets and protocols. The solution calculates projected visit windows per the visit plans and schedules calendar.
Subject Enrollment Tracking
The solution tracks the enrollment status of the subjects in a study for the entire duration of the trial. Subjects can be filtered based on their enrollment status to provide insights on whether the study recruitment is proceeding as planned. Build reports and dashboards against this data to provide stakeholders with KPIs to keep studies on track.
- eConsent
Impakt eConsent replaces paper-based informed consent documents with interactive, multimedia enabled, and template-driven informed consent on mobile devices. The solution is fully integrated with Impakt eClinical-DCT enabling real time visibility and central tracking of enrollment metrics across the studies.
- eCRF
Impakt eCRF (electronic case report form) is a cloud-based, easy-to-use solution that enables rapid data collection, efficient data cleaning, and an overall decrease in the efforts and costs involved in the data management process.
Integrated Patient Recruitment
Impakt eClinical-DCT comes with an integrated Impakt patient recruitment solution which offers study listing on a public website, patient portal for easy registration, self and pre-screening, appointment scheduling and eConsent and instructions.
Integrated with Safety
Our eClinical-DCT solutions easily integrate with our centralized cloud-based pharmacovigilance software solution for advanced analytics set-up along with data integrity. It empowers the end-user with proactive pharmacovigilance, smart features with data-backed predictability, scalability and cost-effective support.
Direct Data Capture (DDC)
Capture clinical data directly in the Impakt DDC solution in real time and integrate with other electronic sources such as EMR/EHR, diagnostic devices and wearables without the need of a paper source.
eCOA, ePRO & eDairy
The Impakt eCOA solution replaces conventional paper-based, patient-reported outcomes by leveraging innovative technologies to capture clinical outcome data. This includes ePROs, ClinROs and eDiary functionalities. Our solution is mobile friendly, supports time-sensitive data collection, enables upload of multimedia content for better patient education, and uses various edit checks to minimize data errors.
- eRegulatory
Impakt eClinical-DCT comes with an integrated eRegulatory solution complete with a configurable site binder structure supporting both industry standard eISF or custom binder structure. Clinical trial documents can be saved directly into eRegulatory upon review and approval.
With integrated sponsor and CRO portals, sponsors and CROs can directly access regulatory documents from the eRegulatory solution and transfer to their respective eTMFs, as applicable.
- eSignature
Impakt eClinical-DCT supports FDA 21 CFR part 11 compliant eSignature and eliminates the need for paper-based documents.
Enable Remote Monitoring & SDV
Impakt EDC allows efficient source data verification to ensure that clinical and patient data collected are accurate, complete, and verifiable. Identify data discrepancies through 100% SDV or set algorithms to perform SDV on specific and relevant data items such safety data, primary or secondary objectives, and more. Easily set up edit checks within the system and risk-based monitoring workflows.
Sponsor / CRO Portal
Access to clinical data can be expanded to Sponsors and CROs to gain real-time visibility on study progress, source data verification (SDV), and quality controls in real-time.
- Payments
Impakt eClinical-DCT is integrated with the Impakt payment module. The solution comes with creating study budgets based on visit schedule and upon completion of the visits, the system can auto generate payments based on visits, procedures, investigator fees, pass through fees, subject stipends, and more.
Integration with EMR & EHR
Impakt eClinical-DCT is built on the best-in-class Salesforce platform comes with open APIs and has the ability to seamlessly integrate with EMR and EHR systems leveraging HL7. Centralize all data in a single system with easy one-way or two-way integrations.
Key Benefits
Impakt eClinical-DCT is built 100% native on the leading Salesforce platform and comes with deep clinical research eClinical-DCT capabilities.
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