Our implemented systems assuring the quality of every aspect of the trial are based on quality standards of Good Clinical Practice (ICH/GCP) and best industry practices. Within the systems we systematically plan and perform actions to ensure that the trial is performed in compliance with protocol, GCP and applicable regulatory requirements.
To provide our stated quality, we start from planning ahead, then implementing the plan and making real-time corrections while settling the issues, responding to queries, analyzing deviations and implementing preventive actions. This system of “planning – doing – reacting – analyzing – acting” is the heart and soul of our quality management.
Conducting our Smart Feasibility Process (SFP®) we ensure that proper investigational sites are involved in your projects. By planning sites participation in advance, we prepare ourselves for upcoming interaction and also help site staff get themselves better prepared by identifying the sponsor’s expectations more clearly.
Patient recruitment strategies and enrollment facilitation algorithms are in action at the study start-up. It’s important not only to get subjects fast, but also make sure that the patients entering the study meet inclusion and exclusion criteria and have all evidence of their eligibility properly documented. We conduct this kind of checkup as a part of our Medical Services activities.
Monitoring sites, especially through monitoring visits, is still the most important part of quality assurance. With our monitors strategically positioned, we stay in control of site’s performance and overall commitment fulfillment. By developing symbiotic relationship with the investigators, we are prepared to identify and act promptly on any emerging setbacks. Thinking logically and strategically we try to go beyond conventional working from a checklist.
When your study is in progress full speed, subject retention activities and data management enhancement come into play as part of our Site Management service. We raise share of voice of your study with investigators, facilitate utilization of your web-based study systems, and provide oversight of site’s activities.
To keep the processes flowing fast and smooth we engage our Project management techniques. With the aim of providing consistent study results and clean data, we work on risks mitigation and issues resolution. Our managers take full personal responsibility for communication with sites, CRAs and the Sponsor and are ready to provide rapid response to requests and inquiries. We minimize communication barriers with investigators by utilizing sponsor’s Clinical Trials Management Systems (CTMS) and the benefits presented by integrated data.
To ensure that essential quality assurance procedures are performed we have developed and implemented full package of SOPs covering all our core operations:
- Site feasibility procedure;
- Monitoring procedure covering risk-based monitoring;
- Electronic documents management procedure;
- Regulatory submissions procedure
- Site contract procedure
Vendor qualification & management procedure, and others.
We offer our quality management consulting as a full-service engagement (Site Management and Monitoring package), but you can order its components only, which are described in more details below.
- GCP audits
Our experienced quality specialists conduct GCP audits, both on-site and in-house. Audits conducted by PharmaSich in Eastern Europe proved to be very effective since our auditors have no language barriers and have practical experience with local regulations and business practices. So they easily identify nonconformancies, precisely identify root causes and assist the auditees to implement CAPA plans.
- Vendor qualification and auditing
It is a good practice to have all local study vendors validated to ensure involvement of compliant and competent service providers. PharmaSich helps its customers to validate and to audit their local vendors including IMP depots, country level Central Labs, couriers, IMP destruction vendors, CROs etc.
- SOP writing
We develop clinical research SOPs for sites, Ethics Committees, IMP depots and clinical labs.
- Quality oversight of clinical trials
This service is actual for customers who have no operations in Eastern Europe and act through their subcontracted providers. We ensure quality control of their vendors in the course of the study. This is done by collecting feedbacks regarding vendors’ performance from investigators; co-monitoring visits with the CRAs of a managing CRO; communication with vendors and sites to identify zones of operational, regulatory, logistical, medical and administrative risks and development of comprehensive solutions to fix it.
Please, feel free to contact us on any business need that you have at your hand to get more information on the services we provide and the assistance we can offer to help you move on with your project. We want YOUR project to become OUR successfully accomplished project!