Quality Management by Pharmalys
Quality is more than a goal – it is our promise.
- Are you sure your Standard Operating Procedures are followed?
- Do you think you are inspection ready?
- When was the last audit on your internal processes performed?
- Have you audited your vendors recently?
At Pharmalys, our Clinical Quality Assurance experts are used to overcoming Quality challenges through:
Benefit from our Contracted Services
Investigator Site Audit
Vendor Audits: Phase I center, vendor and GCLP audits
Project Audits: TMF, safety project and database audits
Document Audits: Protocols, Clinical Study Reports
Inspection Support: Inspection readiness, regulatory inspection preparation visit on-site, site and sponsor inspection support
Additional Services: GCP/GCLP training, SOP development, GxP consulting
Good Clinical Laboratory Practice (GCLP) Accreditation Scheme Operated by Pharmalys
As a laboratory analysing samples from clinical trials:
- Would you like to achieve excellence and stand out from your competitors?
- Would you like to increase productivity and streamline your operations?
- Would you like to strengthen your reputation and enhance trustworthiness?
The GCLP Accreditation Scheme allows laboratories to demonstrate compliance with international standards, ensuring:
- Reliability, quality and integrity of data
- Regulatory acceptance by global agencies
- Protection of patient rights and confidentiality
Who is concerned?
✔ Hospital Laboratories
✔ Central Laboratories
✔ Company Laboratories
✔ Research Laboratories
✔ Investigator Site Laboratories
Drug Safety and Medical Monitoring by Pharmalys
Safeguarding patients, powering clinical success
- Do you seek for 24/7 medical expertise and support during your clinical trial?
- Have you planned risk minimisation strategies?
- Would you need help to develop Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Safety Update Reports (DSURs)?
Benefit from our local expertise combined with international regulatory alignment
- Medical Monitoring and Drug Safety including protocol review and design, safety monitoring, review of Adverse Events and Serious Adverse Events, safety reporting to regulatory authorities and ethics committees, development and review of Safety Management Plans, and medical query resolution
- Individual Case Safety Report Management including collection, triage, and data entry from all sources, medical review and causality assessment, reporting to global health authorities, and follow-up for missing information
- Aggregate Report Writing including development of PSURs, PBRERs and DSURs, and risk Management Plans
- Signal Detection and Management including proactive signal detection and analysis, risk-benefit assessment, safety signal evaluation and characterization, and development of risk minimization strategies
- Stakeholder Management including fostering effective collaboration between key stakeholders, and setting and managing the trial oversight committees
- Literature Surveillance including systematic global and local literature monitoring, identification and reporting of safety information
Let us help you navigate complexity with confidence through:
- In-depth understanding of African regulatory landscapes
- Minimised delays and optimised trial safety oversight
- End-to-end solutions
- Working as an extension of your team
Contact Us Today to learn about how we can support your success!
