The patient-centric technology landscape is evolving and creating tremendous opportunities within the Life Sciences industry. At ACL Digital, our Solution Innovation team leverages next-generation digital engineering capabilities and technologies to enable the design, customization and implementation of “intelligent”, Regulatory compliant, Quality-driven business processes and information management systems. ACL Digital Technology Practice Areas, such as “Connected Technologies” (IoT, Cloud and Mobility), “Intelligent Technologies” (Big Data, Data Science, AI/ML, RPA Cloud Computing) and “Digital Experience” (UI/UX), uniquely positions our company for the deployment of relevant next generation Technology platforms, Business Intelligence and Data Analytics tools to serve cross-functional applications in Medical Devices, Digital Health, Pharma and Healthcare space.
eQMS – DIGITAL QUALITY MANAGEMENT SYSTEM
In collaboration with our partners, ACL Digital enables a flexible, modular, cloud-based, compliant, connected Quality Management System (QMS) designed to integrate Quality processes and maintain the Quality System in a state of constant audit and inspection-readiness.
Some modules in eQMS:
- Document Control: Automates document routing, delivery, approval processes, version control, retention and retrieval in compliance with 21 CFR Part 11
- Change Control Management
- Corrective and Preventive Action
- Non Conformance: Addresses non-conforming materials, components, parts, finished products, streamlines non-conformance disposition, speeds up turnaround time from initiation to approval
- Audit Management: Automates planning and scheduling of audits, provides checklists with audit scoring, powerful analytics and reporting
- Risk Management: Captures all risk-related activities and documentation in a unified repository to provide an updated, accurate picture of the risk landscape across the product lifecycle
Real-World Data (RWD), Real-World Evidence (RWE) & Advanced Analytics
It is a paradigm shift in clinical evidence generation to move away from singular dependence on placebo-controlled clinical studies to now include Real-World Data collected from healthcare practice. ACL Digital’s RWD solution is capable of mining and integrating data from multiple sources such as EHR (Electronic Health Records) and registries, transforming the aggregated data set into meaningful Real-World Evidence using advanced data analytics algorithms, based on the intended use of the therapeutic product.
RWE helps expedite response to strategic regulatory questions, shortens the submission/approval process and time to market, enables physicians to come up with personalized treatment plan and deliver personalized therapy faster to the target patient population (clinical decision support), supports design of more effective trials and outcome-driven reimbursement decisions.
Our analytics services include
- Ingesting Real-World clinical data in industry-standard or custom format
- Analyze data using advanced statistical models and data visualization tools
- Facilitating the publication of clinically relevant scientific reports based on RWD/RWE
- Positioning RWE to support Regulatory filings
Remote Patient Monitoring – Wearable Devices & Embedded Sensors
Embedded sensors in wearble devices and backend algorithms collect and process vast quantitites of data during remote monitoring of patients, either in a clinical trial setting or during post-approval clinical follow-ups (PMS activities), in case of commercially launched drugs. Such data can generate valuable insights regarding patient’s clinical status, therapeutic interventions and deviations from clinically validated “normal” or “reference” ranges. The monitoring devices can send alerts to designated entities, such as physician’s office or medical providers, via mobile apps.
ACL Digital has expertise in design, development and Regulatory strategy of such IoT enabled wearable sensors that collect and securely transmit confidential patient vitals, thereby eliminiating the need for patient site visits and enhancing the overall patient experience. For clinical trial, the processed data can be integrated into an EDC database, so the study team can access, monitor, analyze and report the study data.
Clinical Solution – Blockchain Clinical Trial Platform
Blockchain Technology introduces a new age of data immutability, security, transparency, privacy and traceability. ACL Digital’s PharmaLedger™ is the first web-based Blockchain ledger solution for Clinical Trial Endpoint Adjudication, allowing sponsors, CROs, sites and vendors to exchange communications, queries, and documents conveniently and securely. Study Teams, Committee members, and Site Investigators can work online in real-time from anywhere to expedite judgments, consensus, and completion of the Endpoint Adjudication process.
The system features configurable dashboards, intuitive workflow, search engine and archives, provides the highest levels of compliance and security, and can be used as a standalone platform or easily integrated with other clinical platforms and systems.
Automated Literature Review in Pharmacovigilance & PMS
Pharmacovigilance (PV) and Post-Market Surveillance (PMS) involve labor-intensive manual processes dealing with high volumes of data to identify, assess and report Adverse Events (AE) and Safety related incidents. To address the AE reporting burden, ACL Digital works with its partners to offer custom scientific and medical literature search solutions based on specific requirements, employing RPA (Robotic Process Automation) driven Automated Literature Review. Monitoring of digital content has been simplified through automation of the repetitive processes. The system monitors and collects relevant information from designated data sources based on well-defined search constructs (time to conduct the search and retrieval work is significantly reduced), limiting the expert manual intervention to only those processes where the impact will be maximized, such as an in-depth review
or assessment. A technology-enabled PV process can be a much cheaper option in the long term, since the initial set-up costs will be offset by relatively low operations costs (license, maintenance costs, etc.).
Updating Product Safety, Clinical Performance and Risk Management related reports, in compliance with EU MDR 2017/745 or EU IVDR 2017/746, requires periodic monitoring of Medical Journals, specific databases (MAUDE, BfArM database, etc.), and social media sites. Automation can play a major role here in optimizing cost, resource and timeline for these initiatives.
Global Regulatory Information Management
Global Regulatory Information Management can be quite complex, depending on the number and category of on-market and pipeline products (in clinical development), country-specific affiliates and subsidiaries, types of post-approval changes and unique compliance requirements of Regulatory Agencies in different geographies. Global companies struggle with lack of harmonized data structure and lack of visibility of specific filings due to disconnected systems and processes. ACL Digital, in collaboration with its partners, offers a suite of cloud-based applications that unifies tracking of global filings and registrations, submission content management and dossier publishing. This integrated approach builds efficiency during the filing process, minimizes gaps in compliance and discrepancies, ensures information is relevant, accurate, timely, and accessible.
One comprehensive RIMS will enable our clients to:
- Respond faster to changing regulations, compliance concerns and Health Authority requests
- Respond faster to product changes (e.g., formulation changes, design changes, etc.)
- Increase process efficiency from submission planning to publishing
- Develop reliable Regulatory content with high data visibility, integrity and quality
- Streamline business processes involving Clinical, Quality and Safety function
- Coordinate Regulatory efforts across multiple sites and partners
Pharmacovigilance Process Automation:
To ensure quality AE reporting without any human error, the PV process needs to introduce some degree of process automation.
- Automate Case processing system - includes Safety data entry, data processing, data analyzing, trending, preparing AE metrics, Quality Review, and REPORTING using RPA and data analytics tools
- Mobile application for real-time collection of AE data FROM DIFFERENT SOURCES, integrated with cloud-based Safety database
- Proactive Signal Detection for monitoring of product safety during the entire product lifecycle, including post-marketing phase, through the use of data analytics and Business Intelligence (BI) tools.
ACL Digital has the capability to support CROs, pharma and biotech companies in the PV space through consulting, conducting gap assessment, development of automation strategy, and overall planning for end-to-end PV transformation. Traditionally the Lifesciences companies are slow in adopting new technologies in PV. Partnering with ACL Digital, with established capabilities in digital transformation (big data analytics, cloud-based solutions, mobile application, cognitive computing, and AI), will enable Life Science companies implement such a transformation in PV delivery, deployment of Safety technology, PV Quality Assurance and Regulatory reporting. Such an initiative will help reduce the overall effort and cost, also allow the resources to focus more on proactive identification of Safety related incidents in an effort to minimize risk.