Providing customised FSP models to drive operational efficiencies
At Geistek Pharmaceuticals, we take pride in our capabilities as a leading provider of Functional Service Provision (FSP) on a global scale. Our team of operational, functional, and therapeutic specialists is dedicated to offering a range of customizable FSP models that align with your organization’s specific needs and objectives. By leveraging our suite of capabilities, expertise, and technology, we can enhance your operations, increase R&D efficiencies, and improve site engagement to access patient populations while delivering on timelines and milestones.
1.Study Start-up: We streamline the initiation process, ensuring efficient study site activation and regulatory compliance.
2. Project Management: Our experienced project managers oversee all aspects of your clinical trials, ensuring effective coordination and seamless execution.
3. Clinical Monitoring: We provide expert monitoring services to ensure protocol adherence, data quality, and patient safety
4. Pharmacovigilance/Safety: Our team specializes in pharmacovigilance and safety management, ensuring the monitoring, assessment, and reporting of adverse events and ensuring patient well-being.
5.Clinical Supplies Management: We offer comprehensive solutions for the management and distribution of clinical supplies, ensuring their timely delivery to study sites.
6. Data Management: Our data management experts handle the collection, cleaning, and analysis of clinical trial data, ensuring accuracy and integrity.
7.Biostatistics and Programming: We provide statistical expertise and programming support for data analysis, interpretation, and reporting.
8. Contracts Management: Our team manages contracts and vendor relationships to ensure effective collaborations and compliance with legal and regulatory requirements.
9.Investigator Payments: We handle the timely and accurate processing of investigator payments, ensuring compliance with regulatory guidelines.
10. Clinical Vendor Management & Category Management: We optimize vendor selection and management, ensuring the availability of high-quality services and products.
11.Medical Writing: Our medical writing team delivers comprehensive and high-quality clinical and regulatory documents, including protocols, study reports, and regulatory submissions.
12.Medical Affairs: We provide support in medical affairs activities, including medical information, scientific communications, and KOL engagement.
13. Regulatory Affairs: Our regulatory affairs experts offer strategic guidance and ensure compliance with regulatory requirements throughout the product lifecycle
14. Regulatory Publishing: We provide end-to-end regulatory publishing services, including the preparation, formatting, and submission of regulatory documents.
15.Site Support: We offer site support services to facilitate site operations, address challenges, and ensure optimal site performance.
At Geistek Pharmaceuticals, our FSP solutions are designed to optimize your clinical operations, drive efficiency, and support successful clinical trial execution. Contact us today to learn more about how our customized FSP models can benefit your organization and advance your drug development programs.
INTRODUCTION ¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment