CLINICAL TRIALS & BLOCKCHAIN
Clinical Trials are an essential component of drug development, and it is absolutely crucial that stakeholders guarantee data integrity throughout the whole data lifecycle. Nowadays, trial platforms are fragmented and many diverse players are involved, so ensuring data integrity is more and more of a concern.
Intellegant is developing a clinical trial blockchain-based solution in order to manage and track critical changes to relevant documentation so that all parties involved can be assured that data is transparent, traceable, secure, and accurate. Our solution uses advanced cryptographic techniques, smart contracts, and blockchain technology to retire the filing cabinets and deliver a 21st-century solution for this multi-billion-dollar industry.
We also handle related EU regulation, such as monitoring and compliance regarding the EU Clinical Trial Directive, which is currently being updated with a new Clinical Trial Regulation.
Data Privacy has taken on a new position of importance due to the Global Data Protection Regulation (GDPR) which came into force in May 2018. We provide expert resources to evaluate your firm’s compliance and design and develop a remediation plan to handle GDPR requirements. Our experts can assess your operations to help assure that your systems, processes and procedures protect you from data privacy loss and unauthorized disclosure.
In addition, we provide companies with a framework to assess their information systems and technology capabilities in order to verify if they are fit for purpose and prioritize changes, while making sure to maintain our key focus on practical considerations and business realities.
Data Integrity is becoming an emerging concern and it is a high topic on the agenda of all the regulatory agencies. We help organizations understand regulatory requirements and provide a methodology to embed such expectations into their own systems, business processes and procedures. Our experts can assess your operations to help assure that your systems, processes and procedures protect you from data integrity violations.
In addition, we include a framework to assess clients' information systems and technology capabilities in order to verify if they are fit for purpose and set a roadmap to prioritize changes.
ADVANCED DATA ANALYTICS & SIMULATION MODELING
Data without proper analysis is of no use! With proper analysis of your data, actionable information can be obtained to aid decision making. We provide expert resources to guide you through the journey of advanced and predictive analytics, reporting and decision making that will support your business as your data grows.
Simulation modeling is a new method integrating System Dynamics, Agent Based Modeling, and Discrete Event Modeling techniques into one fully-realized model of a complex situation. By utilizing Simulation Modeling, a company can perform advanced testing and experimentation without the expense of disrupting real-world events, or the risk of implementing an expensive plan only to discover, too late, significant drawbacks.
At Intellegant, our experts have extensive background in operations management, supply chain management and resources planning, mostly focused on Pharma and Healthcare industry. We provide a general management consulting and project management approach based on simulation modeling and data analytics techniques. We use the AnyLogic development platform to attain such results.