Embodying Quality in Every Facet

At Accelsiors, we view quality not merely as a benchmark but as a defining characteristic of our work. Our vision is to offer exemplary services in all key areas of drug development, with a particular emphasis on Clinical Development. By harmonizing the highest quality management principles with international standards, we strive to not just meet but surpass our client’s expectations.

Our independent team, a beacon of quality assurance, offers transparency to Accelsiors’ senior management and clients regarding the compliance status of the studies we manage. The Quality Management System (QMS) at the heart of our operations represents a blend of our invaluable human resources, refined processes, efficient systems, and robust controls. This unique amalgamation ensures that Accelsiors’ activities in clinical research are consistently aligned with Good Clinical Practices (GCP), guaranteeing participant safety, rights, and well-being alongside maintaining data quality and integrity.

Adapting to the dynamic landscape of clinical trials, facilitated by the ongoing technological revolution, we uphold ‘fitness for purpose’ as our quality definition. We strive to bring clinical trials closer to participants without compromising the utmost ethical standards and data integrity. At Accelsiors, quality is not just a promise—it’s our commitment and our purpose.

Ingraining Quality into Every Aspect

At Accelsiors, we view quality as a fundamental prerequisite, as integral as our core functions. Weaving this ‘fitness for purpose’ mantra into all our clinical and business practices, we ensure our professional team works hand-in-hand with our clients. Our objective is to grasp the distinct requirements of each clinical study or related service we undertake.

Recognizing the crucial importance of the ever-evolving regulatory environment, we house a proficient team of QA and regulatory affairs specialists. Their role is pivotal in guaranteeing compliance with the regulations of the US Food and Drug Administration (FDA), directives and regulations of the European Union, as well as the requirements and recommendations of other pertinent international regulatory authorities. This careful observance is an intrinsic part of our successful medicine development process.

With a wealth of experience and an unyielding oversight mechanism, we assure that all our clinical and other pertinent services align with the International Conference on Harmonization (ICH) GCP guidelines and other relevant laws and regulations. At Accelsiors, quality is not just an assurance—it is ingrained in our ethos and is the cornerstone of our practice.

Elevating “Inspection Readiness” to an Operational Culture

At Accelsiors, we embrace “Inspection Readiness” not as an occasional activity, but as an ingrained mindset that influences our daily operations. We have curated a comprehensive program that imbues this culture of readiness into our business and the studies we conduct.

Our Quality Assurance (QA) team is an amalgamation of seasoned professionals with a wealth of experience across Regulatory Authorities, Big Pharma, and quality assurance responsibilities in international multicenter clinical trials. Their expertise spans all aspects of Quality Management System (QMS) implementation, auditing, support to clinical teams, risk/issue management, CAPA implementation and effectiveness confirmation, as well as preparation for and hosting regulatory inspections.

This team stands ready to guide the execution of a robust Quality Assurance program for your project. Their unwavering support encompasses, but is not limited to, the following services:

• Conducting independent audits of investigator sites,
• Undertaking independent audits of vendors,
• Performing process/system audits,
• Coordinating pre-inspection audits,
• Supporting inspection-related activities,
• Assessing risks associated with submissions.

At Accelsiors, we prioritize an ever-ready culture of compliance, assuring a streamlined journey through the clinical trial landscape.

Unfolding Excellence with Accelsiors’ Quality Assurance Team

At Accelsiors, our Quality Assurance (QA) team acts as the guardians of quality, weaving it seamlessly into every layer of your clinical trial right from inception. Their vigilant oversight aims to pre-empt and prevent errors that could significantly influence the conclusions of clinical trials.

Our QA team sets the quality expectations, defining a robust and tailor-made approach to the quality of services and deliverables associated with your study. They delineate the roles and responsibilities related to quality management for each member of the project team, fostering a culture of quality across the study lifecycle.

Moreover, our QA team establishes a balanced scorecard of key performance indicators, complete with quality improvement thresholds. These indicators are periodically reviewed, triggering the implementation of contingency plans or escalation procedures when required.

With Accelsiors’ QA team at the helm, rest assured that every aspect of your clinical trial is in experienced and dedicated hands, committed to maintaining the highest standard of quality.