Clarity | Algorics

Clarity Plan Clarity Build Clarity Monitor Clarity Review Clarity Reporting

With increasing regulatory focus on risk-based approaches, risk-based quality management (RBQM) has become a core area in clinical development with a strong emphasis on improving patient safety and data quality. Aligning with the ICH-GCP E6, FDA, and EMEA mandates for emerging biotechs can be challenging and demand significant effort. At Algorics, we believe that a regulatory compliant and seamlessly integrated technology ecosystem with robust central data monitoring capabilities is key to a successful RBQM implementation. Our homegrown technology suite Clarity is a modular yet fully integrated solution with end-to-end capabilities to synchronize all quality management (QM) steps defined in Section 5.0 of ICH-GCP E6 guideline, enabling you to manage quality parameters throughout clinical development.

Clarity Plan- Risk Planning Module

Proactive risk planning involves defining and managing overarching monitoring strategies. This involves starting with identifying study specific critical data, processes and associated risks, assigning a risk severity score (low, medium, and high) based on impact, probability, and detectability, to build adequate risk mitigation controls.

Our Solution

Has a seamless workflow for effective proactive risk planning
Built in standard Transcelerate RACT (Risk Assessment and Categorization Tool) library
Captured critical data and processes, study specific risks, risk evaluation, and associated controls into the risk inventory
Custom risk inventory for program level risk management

Clarity Build- Risk Control Module

Risk evaluation methodology enables cross-functional teams to devise robust risk control and mitigation strategies. The cross functional study team need to review risks affecting their respective functions and a well-written Integrated Risk Plan (IRP) form the basis for developing respective functional plans.

Our Solution

Comprises of a detailed Integrated Risk Plan (IRP) template for study teams to draft, review, finalize, and approve
Tracking and version control of the IRP during the study for traceability and final reporting

Clarity Monitor- Risk Surveillance Module

Continued risk surveillance helps monitor the risks identified during the study and evaluate the effectiveness of planned risk mitigations and controls. Data driven risk surveillance via central monitoring is a widely accepted methodology utilizing analytics and a statistical approach for a holistic view of the Patient, Site, and Study level to surface risk signals.

Our Solution

Is a “one stop solution” for central monitoring and analytics
Data driven surveillance across all study dimensions- Patient insights, Site Insights, Central Statistical Monitoring (CSM), and Quality Tolerance Limit Monitoring
Intuitive with robust visualization of clinical and operational data allowing real time data reviews.
Clarity Connect, a data integration module enables integration across data sources into our analytics platform

Clarity Review- Risk Review Module

Risk Review at regular intervals is needed to ensure that the study team addresses the identified risks throughout the study. The risk signals and issues resulting from cross-functional team data reviews (including Central Monitoring) need to be created, tracked, and managed until resolution. Through these risk signals, study teams review any potential emerging risks, the status of the existing risks, and plan for further course of necessary action thereof. Risk Inventory (RI) need to be updated to reflect all the relevant changes during risk reviews.

Our Solution

Facilitates signal management for study teams to create, manage, follow up, and action the risk signals identified
Signal management workflow for central monitor/data reviewer and action owners to create and manage risk signals at various levels and link to risks identified within risk inventory (RI)

Clarity Report- Risk Reporting Module

A signal window risk reporting which summarizes all elements of risk management outcomes within one system enables biopharma companies to efficiently report to regulatory authorities. A summary of the RBQM approach adopted for the trial, quality tolerance limit (QTL) breaches observed during the trial, and associated QTL remedial actions will essentially be a part of the clinical study report (CRS).

Our Solution

An automated tool integrating inputs from all previous modules through a “push-down” mechanism to generate reports
Enables study teams to view the final integrated risk plan (IRP), final Risk Inventory (RI), and signal summaries
Reporter module with custom edits facility to update structure of reports/summaries as per study needs

Risk-based quality management with data driven insights

Why Clarity?

Clarity Plan- Risk Planning Module

Our Solution

Clarity Build- Risk Control Module

Our Solution

Clarity Monitor- Risk Surveillance Module

Our Solution

Clarity Review- Risk Review Module

Our Solution

Clarity Report- Risk Reporting Module

Our Solution

Why Clarity?

Expertise

Flexibility

Innovation

Clarity Plan- Risk Planning Module

Our Solution

Clarity Build- Risk Control Module

Our Solution

Clarity Monitor- Risk Surveillance Module

Our Solution

Clarity Review- Risk Review Module

Our Solution

Clarity Report- Risk Reporting Module

Our Solution