IN PARTNERSHIP
non-interventional studies and real-world evidence studies, with expert project management to prevent and anticipate any possible deviation from the original project objectives through contingency plans. The success of these projects requires rapid patient recruitment and adherence to study us to tailor quality assurance resources to a risk-based approach, focused on client needs and project complexity, also aligning cost and service time with quality in order to meet client requirements. Our in-depth experience of the European regulatory process, and knowledge of sites and investigators, provides our clients with the ability to meet start-up milestones. projects that we provide is based on the technology tools and our experience and resources to manage trials of any size in the
Commitment to quality implemented an ISO 9001:2015 compliant Quality Management System, based on our ‘Service Process Map’, which includes the owner, inputs, resources, risks, controls and key performance indicators corresponding to each of the internal steps during the clinical research process. We have developed the Quality Management System, with a comprehensive list of Standard Operating Procedures (SOPs) to cover the execution of the different services we offer. These procedures are designed to move hand in hand with the client throughout the project, verifying the results through internal quality controls in order to progress quickly and correctly to the next step.
“APICES is proud to have implemented an ISO 9001:2015 compliant Quality Management System based on our Service Process Map”
18 | Outsourcing in Clinical Trials Handbook Our expert project planning and management
will help to reduce project risk and minimise delays, thus decreasing cost and ensuring that agreed deadlines are met to the highest quality. We are acutely aware of the increasing
importance of our clients’ ESG (environmental, social and governance) requirements and strive to be a leading service provider in this area.
Recognition During this time, APICES staff have featured in more than 40 acknowledgments, and even as authors in some cases. Their participation and contribution to the clinical trials has been recognised in high-impact publications, including The Lancet Oncology, Annals of Hematology, Annals of Oncology, Journal of Clinical Oncology, International Archives of Allergy and Immunology, European Journal of Cancer, The Oncologist, and Clinical and Translational Oncology, among others. These continued acknowledgements in oncology and haematology, are not simply a coincidence. Our considerable expertise in running immuno-oncology and haematology trials is considered to be a positive aspect that reinforces this evidence. This is also supported by the fact that, while managing these studies, APICES offers its clients added value, beyond the contracted service itself. Other aspects that may have a favourable influence on these acknowledgements are the team’s deep involvement in the projects and the accessibility to top management, who are on hand to accompany the client until a satisfactory end product is obtained. From the beginning of the project right up to the publication of results, we establish fluid communication and work on building good relationships that allow unforeseen events to be dealt with smoothly, and in coordination with the sponsor. As a result, APICES can be seen as a reliable
client satisfaction, flexibility and partnership vocation, quality and experience in clinical research, as well as global resources. It ensures that its clients are delighted with the services, providing them with maximum satisfaction on their clinical development journey.
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