PT Enterprises Europe, Ltd. is dedicated to eliminating cancer as a global health problem by supporting research that prevents cancer, saves lives, and diminishes suffering through research, education, advocacy, and service.
PT Enterprises Europe, Ltd. in collaboration with other cancer-related organizations throughout the world, has a shared sense of purpose for eradicating this disease.
“We are continually faced with great opportunities that are brilliantly disguised as unsolvable problems.” – Margaret Mead
Solutions
• Driven by passion, dedication and a commitment to patient safety.
• Committed to fighting the battle against cancer and other life threatening diseases.
• Ensure the quality conduct of clinical trials so that safe and effective treatments will become available to those in need.
• Work globally to assist Biotechnology and Pharmaceutical Companies to reach their goals of effective and safe treatment.
• Extensive therapeutic area specialization in Oncology – optimized to work efficiently in this challenging area.
• Well respected by investigators, site staff and sponsors alike in the international biopharmaceutical industry.
• Project experience covers a wide range of solid and hematological tumor indications and therapeutic approaches.
• Conduct thorough project feasibility assessments, enabling selection of the most appropriate countries and investigative sites to meet demands of specific recruitment targets and study timelines.
• Develop innovative, efficient approaches to planning, implementing, conducting and monitoring the logistics of investigational clinical trials.
• Preparation of audit responses for internal and external audits
• Protocol development/CRF development.
• Informed consent development and review.
• Investigator Conference planning and presenting.
• Develop and negotiate study center budgets.
• Ensure that investigator and sponsor obligations are met in accordance with Food and Drug Administration (FDA) and International Council of Harmonization (ICH) Guidelines.
• Assure and maintain Good Clinical Practice (GCP) at investigative sites.
• Clear understanding of clinical research requirements on a global and local country level and have established excellent working relationships with an extensive network of oncology sites internationally.
• Provide a responsive and collaborative approach to the Sponsor’s needs, with transparent business processes.
• Protect the rights, safety, dignity and well-being of research participants.
• Facilitate and promote ethical research that is of potential benefit to participants, science and society.