qointa

© 2018 qointa. All rights reserved. All product names, company names and registered trademarks in this document remain the property of their respective owners.

Digital Medicine A way for pharma companies to be more relevant in healthcare

Healthcare and Lifesciences (clinical research) are currently going through drastic changes driven by the wealth of unqualified vital data that will be generated by patients who will be claiming their more central, empowered role and by the more stringent demands of regulatory bodies.. 

Patient data is now fluid and constantly changing and includes such diverse data sets such as “real time” vitals monitoring, mood, behaviour, quality of life and location which patients allow to be accessed by trusted providers at their own initiative, during the monitoring of their treatment between doctor’s visits or as a participant in a clinical research program.

The problem that today’s Life Sciences organisations are encountering is that the current data environment is siloed in proprietary systems which requires various providers to constantly duplicate patient data sets and it is easier to infringe the integrity of electronic data than a paper record.

Physicians and health care organisations therefore do not have access to real time data sets, review and respond to provide the highest quality of care and research organisations don’t trust the data that is generated in the current systems.

Nevertheless, these patient-generated data are enormously important for all the research/healthcare stakeholders. Therefore there is a need for better services focused on Data Integrity that helps validate the data so that they can be trusted by care-givers and researchers.

Why?

Bringing Innovation and Assuring Quality and Integrity Across the Scientific LifeCycle: Supporting

Challenges and Technology Solutions in future Healthcare Systems & Clinical Research

qointa solutions … a way for pharma companies to be more patient engaged and provide more quality Yet it was - and is - our belief at qointa that the status of technology was leaving us large margins for improvement. Yesterday's off-the-shelf solutions were not doing enough. qointa looked at the future, and decided that the best way to predict it, was to help build it with you … a validated and trusted system to store patient data of which each data point is actionable for all stakeholders.

In the post–Affordable Care Act (ACA) environment, pharmaceutical companies have a clear opportunity to play a greater role in delivering a better experience for patients, improving clinical outcomes, and reducing the total cost of care — the three objectives of the “triple aim” framework. The key is qualified digital medicine technology, which can increase patient activation and engagement through technology. The right application of digital technology can also create new opportunities for pharma companies to revamp their business model.

Every inch won in development, testing, adherence and disease management leads to considerable gains.

Doctors and patients deserve the best. That's why.

from quantified patient to qualified subject

Data integrity is a prerequisite for the regulated healthcare industry due to a direct impact on product quality and patient safety.

Electronic data and computerized systems have introduced new challenges to maintaining data integrity, as it is much easier to change electronic data and records than it is to change a paper or other physical record.

FDA mandates the electronic data integrity through 21 CFR Part 11 and 21 CFR Part 820 regulations. Health Canada has adopted Pharmaceutical Inspection Cooperation Scheme’s (PIC/S) good guidance for compute r i zed sys tems in regu la ted GXP environments, while the European Commission details electronic data integrity requirements in EU EudraLex Annex 11.

As the life sciences industry is focused on leveraging its computerized systems to significantly improve and expand its resources, the regulatory authorities such as FDA, EMA, MHRA, Health Canada have put much emphasis on data integrity in recent years, because they uncovered serious cases of data integrity breaches. For example, FDA recently announced that they would be regularly conducting inspections focusing on 21 CFR Part 11 requirements. UK MHRA also set an expectation that the aspect of the data integrity and traceability would be covered during inspections from the start of 2014.

Due to increasing complexity of computerized systems landscape and lack of a balance between cost, schedule and appropriate level of compliance, the regulated organizations and its vendors often

struggle to implement the most effective and defendable compliance standards, and, as a result, are at a disadvantage when it comes to data integrity.

qointa has specialized in providing a broad range of solutions and services relevant to Electronic Data Integrity and Computerized Systems Compliance, Our services are designed for all companies but we have build up our expertise in the lifesciences market.

Our services/ systems are used/in use by pharmaceutical companies, medical device manufacturers, medical record providers, biotech companies and CRO’s and they can assist you in the following programs:

Some Key Offerings:

Computer Systems & Software Validation • Risk-based framework (GMAP5) • CSV planning, training and support • Technology and Vendor evaluation • Periodic Review of validated state

ICT/IT/IS Quality System and Audits • GAMP5 and FDA QSR-based QMS • Easy-to-follow SOPs and policies • Scalable “As-Needed” approach • Integration with current quality system • Periodic Audits/Assessments

21 CFR Part 11 Compliance • Gap analysis and Remediation • Part 11 technical & procedural controls • Data Integrity controls across the record lifecycle • Part 11 training (“As-Needed” details) • Mock Part 11 inspections

Infrastructure Qualification • Infrastructure compliance assessments • Prospective/retrospective qualification • Maintaining Control • ASTM E2500 and GAMP principles

Clinical Datamanagement Support Services Consulting services for strategic design of Late Phase Studies & Risk Management Programs

• eCOA provisioning • Protocol development, CRF design • Data Analysis Plan & Report development • Study start-up activities • Development of Study Reference Manuals & other study materials • Investigator and Study Coordinator training • Medical writing • Clarify processes and logistical procedures • Respond to questions regarding completion of CRFs, interpretation of data reports, etc. • Vendor Qualification • …

Services

Simple. We save you time, money and stress in sourcing the very best.

In case all that sounds too good to be true, work with us, and we’re sure you’ll feel the same way too.

Delivery Options

• Solution Provisioning • Full project or program ownership • Organizational change control • Center of Excellence principles • Managerial/SME engagement oversight

• Staff Augmentation • Life Sciences & IT recruitment expertise • Long-term retention and utilization

• Fixed Price or Time/Material

Competitive Benefits

• Repeatable and Risk-based solutions – minimizing risk, cost, and cycle time

• Project Management with deep domain knowledge

• o Enabling balance between cost, schedule and appropriate level of compliance

• Technology expertise, spanning across clinical automation, process automation, lab automation and IT

• Unique Validation Accelerator Kit – mapped to GAMP5 and Industry best practices (ITIL, ISO 12207)

• Enabling faster engagement, greater consistency, reduced rework and reduced costs

•• Service ecosystem model involving domain experts, in-

house SMEs, consortium and major industry partners.

Why qointa?

The development of new medicines is critical to improve healthcare. There are still many unmet medical needs and in the ageing world population the proportion of chronic disease is increasing rapidly.

However, the discovery and development of new medicines that are effective and safe for routine use in patients has become increasingly complex, labor intensive and challenging. This is, in part, due to the need to conduct large clinical trials that provide definitive evidence of the clinical benefits and safety of the new compound.

Specific issues include the difficulty in evaluating large patient populations (outcome research), optimizing protocol design and identifying suitable patients for clinical trials (patient registries to patient recruitment), as well as the manual and redundant re-entry of data, the reliability of data sources and the difficulty in detecting and reporting infrequent adverse events (in-life testing).

We have build over the years various excellent products that could help you today. Our focus was always on validating patient data so that each datapoint is actionable for all stakeholders in the healthcare/lifescience eco-system from caregiver to researcher.

Our systems were capable of setting up (complex) patient registry programs where the patients could receive adherence support (treatment, medication, procedure) and get remote patient monitoring/disease management guidance when using multiple point-of-care measuring device. At any moment a clinical trial (eCase report form, eReported Patient Outcome, Randomisation, Trial Supply Management) can be initiated to investigate certain health care outcome objectives

“Engaged patients tend to have better outcomes, and

lower healthcare costs.”

qointa helps lifescience companies bridge the gap with patients and helps them provide better care

Patient Engagement … the first step to holistic patient management and improved real-world outcomes

All qointa products & services are compliant with all current regulatory and privacy directives.

qointa is committed to provide world-class products and services that meet or exceed our customers' requirements and all applicable legal and regulatory requirements

Our continuous quality improvement process, governed by our Quality Assurance System, has procedures to cover Management Responsibility, Internal Audits, Personnel, Design Control, Software Development Procedure, Document Control, Purchasing Controls, Corrective/Preventive Action, Records Retention, Control of Quality System Records and Customer Complaints.

All our software development follows documented procedures with clearly defined processes and deliverables, governed and measured by our Quality Assurance System.

The objectives of the Quality Assurance System are to:

• Establish clear lines of authority and responsibility with respect to quality management. • Maintain an effective Quality Assurance System in compliance with applicable legal and

regulatory requirements and ICH GCP guidelines relevant to the conduct of clinical research studies.

• Maintain an exceptional level of quality that enhance qointa's reputation in the industry. • Maximise internal and external customer satisfaction with the products and services

provided by qointa. • The Quality Assurance System is defined in the following controlled documents: Quality

Manual • Standard Operating Procedures (SOP) • Quality Records including specific project-related documents Processes

Quality?

Succes Stories:

• Part 11 remediation for a global Pharma major • eClinical validation at a global Pharma major • LIMS validation at a global Pharma major • Legacy IT Compliance remediation at a global Medical Device company • Software validation for a Medical Device major • IT Infrastructure / Data Center Qualification for a global Pharma company • GxP compliant cloud implementation for a global Pharma major

Use case:

Our system is capable of setting up registry programs were the patients will receive basic adherence support and will get remote patient monitoring guidance when using any point-of-care measuring device.

At any moment a clinical trial can be initiated to investigate certain objectives. The clinical trial will be handled completely on-line with the re-use of the patient data already available. The clinical trial contains all elements that are required to initiate the trial fast.

At any moment the patient can be enrolled in complex bi-directional adherence programs or disease management programs to get the support he requires to stick to his treatment plan.

Any questions about your project, please contact us.

Experience

Total experience: # eCRF trials: +50 (all phases, + randomization, supply management) # ePRO (eDiary) program: +10 # Adherence projects: +20 # Clinical trials with remote patient monitoring/ wearables: 3

Personal records per trial: 32 countries, 33 languages duration: 96 + 36 months +3680 eCRF, +1250 eDiary, +1500 Adherence patients +550 sites

qointa is assisting companies between the science of medicine, the practice of medicine and the future of healthcare by engaging technology, developers, experts and the practitioners into direct dialogue, resulting in new faster to market-cures for disease and improved treatment modalities.

qointa is committed to reshape • the future of clinical trial management  and related processes (eCOA

provisioning, Data Integrity) in the Life Sciences industry • the future of healthcare by giving the patient access to a health record

that can be directly used by the caregivers and researchers • the future of care by offering the patient the right data and right tools to

manage his health • … Our team includes highly qualified professionals with extensive technical and clinical experience. They understand how to translate your clinical data requirements into a smart designed case report forms and dataset deliveries because they speak your language and see your needs from a clinical perspective.

Our team had always an strong affinity with quality and processes, that is why we became experts in helping our clients with any quality related topic from Software Validation to Data Integrity.

Your challenges of today in using multiple systems with patient data or handling your next eCOA provisioning project can be taken on by us.

We believe in building long-term partnerships through commitment to quality service by providing you reliable resources, strong management support, honest communications, and transparency in all of our dealings.

Small data is the data about you. Big data helps you understand what the s m a l l d a t a m e a n s . T h e y ’ r e complementary and necessary. Simply having a lot of big data doesn’t get you very far … the true value lies in qualified small data …. qointa

Contacts www.qointa.com sales@qointa.com

qointa

www.qointa.com