A quality and technology thought leader in the field of digital health, passionate about the patient experience

Pharmassure is a leading provider of software solutions that automate the process of creating, maintaining, and updating Pharmacovigilance System Master Files (PSMFs). Our solutions help pharmaceutical companies streamline their PV operations, reduce costs, and improve compliance with regulatory requirements.Products and Services:• PSMF Automation Software: Our flagship software solution automates the entire PSMF lifecycle, from initial creation to ongoing maintenance. It provides a centralized repository for all PV data and documents, and it automatically generates regulatory reports.• PV Consulting Services: We offer a full range of PV consulting services, including PSMF development, PV process optimization, and regulatory compliance audits. Our team of experts can help you implement and maintain an effective PV system.Benefits of Pharmassure Solutions:• Reduced Costs: Our solutions can help you save up to 70% of the time and cost associated with manual PSMF management.• Improved Compliance: Our solutions ensure that your PSMFs are always up-to-date and compliant with the latest regulatory requirements.• Increased Efficiency: Our solutions automate many of the manual tasks involved in PSMF management, freeing up your staff to focus on more strategic activities.Pharmassure solutions are designed for pharmaceutical companies of all sizes, from small startups to large multinational corporations. Our solutions are also used by contract research organizations (CROs) and other organizations that provide PV services.Contact us today to learn more about how our PSMF automation solutions can help you improve your PV operations and reduce your risk of regulatory non-compliance.

Navigar’s primary mission is to signpost data, ensuring that access is available for the patient community and ensuring the patient is an active participant in their health journey.Navigar will achieve this through disrupting the traditional mechanisms of indexing and transferring data from clinical institution to clinical institution and utilize ledger based technology, to ensure a complete Rubicon of those data exist. This will deliver data, faster, more complete, and more efficiently ensuring that those data are available in real-time to treating physicians, the patient and to researchers globally, all with the patient in control of their data.Navigar is proud to present its lexicon approach to data handling and indexing, that will be the backbone of every system worldwide that handles, stores and utilizes patient data on a second-by-second basis.

Esi-Data was formed to tackle a distinct pain point in the biopharma industry. What do you do with data when the trial ends, how is this disseminated to the clinical investigators and how do they store it? This has been the problem of our industry for the last 20 years when we apply for approvals, supplemental applications and new indications. This costs on average $500 Million in lost revenue when supplemental applications, new indications of paediatric submissions fail due to missing or inaccurate data.**We are currently inviting biopharma and clinical investigators to contact us for partnership opportunities**Our solution:Traditionally we have sent data on memory sticks, CDs, downloads, used Sharepoint, Box and a number of other totally unevaluated tools as this is the investigators data, and not the direct responsibility of the sponsor. But what happens when the inspectors call? How do we ensure data is present at the clinical investigators site and they have control of that data?We provide a fully compliant and validated solution, to ensure that the clinical investigator has full and total control of their data, and the Sponsor knows those data exist and that in the event of an inspection, licensing or acquisition activity that the investigator can retrieve those data for review independently of the Sponsor.

Also within this role the following other roles were incorporated during the tenure;Head, Global Corporate ComplianceHead, Global Good Clinical PracticeHead, Global Good Pharmacovigilance PracticeHead, Global IT Quality

Recruitment Recruiting candidates that best fit the job profile, and identifyingtalent. Competent at selecting and appointing high performanceindividuals.People management Manage a diverse team across the globe, with many cultural differencesDepartmental management Managing the direction, goals and vision of department, taking intoaccount both the company and the individual to achieve strategicmilestones.Employee development Assessing training needs of staff, and applying knowledge to train employees to a high standard, also understanding the needs of the employee.Performing regular performance and development meetings withindividuals.Strategic decision making Demonstrated prudent risk taking, decisions are taken based uponfact, decisions taken to drive innovation.Liaison with regulatory authoritiesServed as a key liaison with ranking regulatory authorities, andparticipated in a large number of regulatory inspections.Obtaining results through others Highly experienced in planning yearly and quarterly schedules, including follow up work, and managing a results driven process with measures included to identify success & progression.Budget/ Finance Experienced in working with budget estimates, projections for forthcoming years