Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development

In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic.

With therapies in various phases of clinical development, the path is both thrilling and challenging. Organizations can partner with a dedicated research and compliance consulting organization, like ProPharma, for not just beneficial, but transformational changes.

Clinical Quality departments may find it difficult to balance the demands of their daily compliance requirements and the requirements of Health Authority regulations. As these companies navigate the intricate path of clinical development, having robust clinical quality assurance support is crucial, and can ensure quality and compliance at every phase of development.

Navigating the Regulatory Landscape

One of the most daunting aspects of clinical development is the ever-evolving regulatory landscape. Keeping up with changes in regulations, guidelines, and standards is a full-time job. Clinical quality assurance compliance experts specialize in understanding and anticipating these changes, ensuring that your clinical development processes are always aligned with the latest requirements and are “right sized” for your organization’s clinical GxP needs. The partner you choose should bring a proven approach that anticipates and mitigates risks of non-compliance, saving your company from costly delays and potential penalties.

Key benefits of a right sized Clinical & Development Quality Assurance Department

1. Protecting Patients: Ensures patient safety in clinical trials.
2. Ensuring Reliable Data: Assures data accuracy and credibility.
3. Conformity with Regulations: Complies with FDA, EMA, and other regulatory standards.
4. Improved Trial Efficiency: Quality by Design (QbD) can lead to improved trial efficiency.
5. Enhanced Data Quality: QbD can also enhance data quality.
6. Increased Patient Safety: QbD can increase patient safety.
7. Quality Assurance (QA): A well-trained team of QA auditors can ensure successful trial outcomes.
8. Trial Site and Vendor Pre-Qualification: A QA team can assess a site or vendor (on-site or remotely) to ensure that there are adequate quality management systems and standard operating procedures in place.
9. Increased Confidence with Clients.
10. Continuous Process Improvement and Compliant Quality Management.
11. Ensure Qualified Personnel are in place to perform essential services.

Mitigating Risks, Maximizing Efficiency

The path to clinical success is fraught with potential risks, from regulatory non-compliance to operational inefficiencies. Organizations should proactively identify and mitigate these risks before they become obstacles. Through comprehensive GxP audits, risk assessments, quality management system development, mock PAI inspections, and continuous monitoring, you can address potential issues proactively, ensuring smooth and efficient clinical operations. With this type of proactive approach, you not only minimize the risk of costly delays but also optimize resource allocation, maximizing the efficiency of your clinical development programs.

Examples of Risk Mitigation Activities

1. Standard Operating Procedure (SOP) writing, revisions/updates, and reviews as a QA Consultant or ad hoc SOP by SOP or throughout your Quality Management System (QMS).
2. Complete a Gap Assessment, complete with Remediation Plan to assess performance of a business unit to determine if requirements and oversight are being met and identify potential steps that should be taken to improve any deficiencies.
3. Assessments of Vendor Management Programs: Performing a clinical review of the Vendor Management Program SOPs, Work Instructions (WIs), risk assessment procedures, and materials used to qualify/re-qualify vendors, and assessing/re-assessing frequencies to re-qualify vendors.
4. Alignment of Good Manufacturing Practices (GMP) SOPs to clinical SOPs: Clinical Quality consultations to move or re-structure GMP SOPs to include clinical or Good Clinical Practices (GCP) terminology when entering a clinical market.
5. Management of clinical quality issues/events (QIs/QEs) with vendors/CROs: Communicating with vendors including making clinical QA requests of supporting documentation, documentation verification and review, and follow-up communication.

In Summary

For any sized pharmaceutical and biotech companies, the journey of clinical development is both an exciting and challenging endeavor. Partnering with a compliance consulting company, like ProPharma, for clinical quality assurance support transforms these challenges into opportunities for growth and success. By ensuring excellence in every phase, mitigating risks, strengthening data integrity, promoting ethical standards, and facilitating regulatory submissions, Clinical Compliance and Quality Assurance activities can unlock the full potential of your therapies. Together, you can advance science, improve patient outcomes, and bring life-changing treatments to those who need them most.

Build a Culture of Clinical Compliance with ProPharma

One of the most significant benefits of partnering with ProPharma is the empowerment of your internal team. Through tailored procedures, targeted training, and ongoing GxP consultant support, we equip your team with the foundation necessary to achieve and maintain high quality standards of clinical quality independently. By investing in your team’s capabilities, you ensure sustained compliance and quality, fostering a culture of excellence within your organization.

ProPharma’s globally distributed Clinical Quality Compliance team consists of experienced professionals with pre-clinical, clinical, and commercial quality expertise. Our standardized processes adhere to respective health authority guidelines worldwide. Freeing up valuable time from our client’s quality units.

As our team custom tailors organized, cost-efficient clinical system solutions aligned to the type of GxP support needed while also reflecting current industry and inspectional trends. Our extensive experience with CROs, Sponsors, Site Management, IRBs, manufacturers, testing labs, packagers/labelers, distributers, software vendors, and general service vendors is combined with our deep experience in GxP oversight, making ProPharma an ideal partner for complete clinical quality program support, while allowing your quality team bandwidth to focus on compliance initiatives.

Ways ProPharma helps Clients build Clinical Quality Compliance

1. Trend and track key performance indicators (KPIs), while assessing existent and expanding the list of KPIs for tracking and trending in areas such as vendors/CROs, clinical trial sites (investigator sites), quality issues, and milestones in clinical trials.
2. Design and build customized tracking tools (trackers) for clinical QA to track KPIs for in-house use.
3. Conduct on-site and/or remote audits on behalf of your team/company including investigator site audits, GCP/GLP audits, internal/external audits, on-site regulatory inspection readiness visits, and quality visits of investigator sites.
4. Conduct GAP Assessments of your QMS and clinical trial practices/procedures as needed/requested with remediation of potential or actual GAPs in your systems.

Contact us today to speak with one of our clinical quality assurance experts about your needs. 

Author

James Meckstroth

Senior Director, Compliance & Quality Assurance