Benefits for Sponsors

Unified Hybrid data collection platform

CliniOps App and DeCentralized Clinical Trial suite is a Clinical Data Capture and Management software that support electronic data collection either at sites or at patient homes using electronic devices or wearables or Integrated Internet of Things devices (IoT devices), by either the patient themselves or mobile HCPs, ensures Clinical data is captured electronically. CliniOps is a robust and scalable platform for any type of trial requirement.

High Return on Investment

Several manual activities are significantly reduced such as , storing data, onsite monitoring, source data verification, query resolution, thereby reducing time and money and providing a high ROI for sponsors.

Fail early, Fail Fast

Faster Real Time Clinical Data Collection and analytics provide an opportunity to learn the results of a clinical study much early in the clinical trial life cycle helping to save more time and money.

Real-time Adverse Events

Being able to respond and change course as needed is a critical requirement for any Clinical Trials. Being centrally managed, CliniOps solution enables the sponsors to be alerted immediately for adverse events, thereby ensuring prompt action is taken as needed.

Real-time Data science

CliniOps provides access to all the stakeholders to view the same data, under a Unified Data Collection platform in real-time, providing opportunity to all the stakeholders to monitor the clinical trial progress with actionable insights..

Regulatory Compliance

eSource Data produced by CliniOps meets the highest quality standards from various national and international standard organizations. CliniOps follows quality by design and the product suites are HIPPA and 21 Part 11 compliant, and follows CDISC data standards. CliniOps is also a ISO certified company

Benefits for CROs

Fast and Standardized Study setup

CliniOps built-in CDASH compliant form libraries ensures faster study setup, with pre-mapped data fields for easy downstream statistical analysis.

Minimal query resolution

With digital data collection with system queries at point of care, and no manual transcription or source data verification, the data quality is very high significantly reducing downstream query resolution.

Minimal travel to sites

Monitors can minimize their travel to sites and perform the activities from the comfort of their location.

Remote SDV (rSDV)

With source data being digital, CROs can now perform remote source data verification based on access control, roles and responsibilities. Minimizing onsite monitoring significantly cuts down the time and budget.

Faster DB Lock

With minimal downstream query resolution and digital data collection following global data standards, the effort to complete the LPO to DB lock is minimal.

Real Time Analysis

CliniOps provides a single source of truth that helps the sites and researchers to start using the data in near real time and obtain the progress in real time to make rapid decisions.

Benefits for Sites

Flexibility to collect data at hospital or patient home

HCPs can easily collect data at hospital or at patient’s home using CliniOps mobile technology. Data can be collected from patient homes ether by patients themselves or by mobile HCPs as needed

Outreach & Diversity

With the flexibility of remote data collection, sites can now significantly increase the patient outreach, and thereby also increase diversity of patient population.

Electronic source data (eSource)

Empower sites with the right technology to enable seamless electronic source data collection at the point of care, via mobile technology. Built-in checks and balances in offline mode, ensures clean data collection at source, thereby significantly increasing data quality.

Patient retention

CliniOps supports and maintains strong relationships with patients throughout the clinical trial. Ensures continuous monitoring of the patient data and providing impeccable patient experience, also ensuring reduced drop-out rates.

No clumsy paper handling

CliniOps Smart eSource solution and cloud storage eliminates the need for paper handling, costly GCP compliant archival, and ensures the process is Audit friendly.

Integrate Remote Medical Teams

CliniOps helps manage remote Nurses and Phlebotomists to collect patient data remotely and send it securely to the sites for the next steps. This helps the sites to deploy a remote team on demand which saves expensive trips to a) Collect the data and b) have it verified. Since the source itself is electronic, it saves time and money for sites and as well as the trial as a whole.

Benefits for Patients

Patient centricity

CliniOps Decentralized Clinical Trials are designed around the patient, focused on delivering the right care, at the right time and at the right location.

Patient engagement

Encourages patient engagement in clinical trials via newsletters, information brochures and digital interactions for better clinical trial experience.

Comfort from home

CliniOps solution extends the data collection capability to patient home giving patients the comfort and convenience from their home

Minimal travel

CliniOps solution helps capture data from patient home, eliminating travel to trial sites, often with additional care givers and spending hours at the hospitals.

Alerts and reminders

Timely notification to patients to complete the daily tasks helps ensure protocol adherence.

Continuous monitoring

Patients can be continuously monitored and symptoms can be collected in real time, so patients don’t have to remember them during visits..

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