The pressures arising from stricter regulations, evolving technologies, and globalization place current operational models and information infrastructure under significant strain. As these pressures continue to mount, it becomes increasingly crucial to choose the right model and employ the appropriate methodology to anticipate the challenges encountered during clinical trials and enhance project success.
At Geistek Pharmaceuticals, we specialize in guiding sponsors to select the most suitable model – whether it be traditional, decentralized, or hybrid – that effectively addresses the unique clinical development challenges of each study. Our team of experts crafts customized solutions to optimize patient recruitment and retention, while also expanding access to diverse patient populations. Through close collaboration with you, we develop strategic and adaptable approaches that leverage clinical informatics, cutting-edge technologies, and our global presence to maximize safety, efficiency, and data-driven decision-making for every study.
Our vast expertise spans various functional and therapeutic areas, including cardio-metabolic, oncology/hematology, infectious diseases, neurology/psychiatry, rare diseases, respiratory conditions, and biosimilars. At Geistek Pharmaceuticals, we are committed to providing you with the benefits of our extensive specialized knowledge in these domains, ensuring top-notch care for each project.
Geistek Pharmaceuticals is a leader in clinical trial innovation, leveraging our profound statistical knowledge to design cutting-edge trial methodologies. Our industry-leading team focuses on all phases of drug development and therapeutic areas, ensuring more accurate decision-making through comprehensive trial design. We offer a wide range of support options, providing cost-effective solutions that prioritize accuracy and timely delivery.
Our services encompass statistical consulting, data integration and standardization, adaptive and Bayesian designs, independent data monitoring committees, specialized medical device trials, and regulatory submission support. Our experienced staff guides clients through complex regulatory requirements, saving costs and accelerating time to approval. With a global team of over 300 professionals, including experts in experimental design and regulatory compliance, at Geistek Pharmaceuticals we guarantee compliance with the latest standards and guidelines.
Every member of our team is trained in CDISC SDTM and ADaM compliant data structures, with a successful track record of converting trials and meeting regulatory requirements. At Geistek Pharmaceuticals, we are committed to providing tailored solutions and invaluable insights, ensuring the success of our clients’ clinical trials.
Geistek Pharmaceuticals is a renowned leader in the field of clinical trial innovation. Our extensive expertise in statistics enables us to design cutting-edge methodologies that drive the advancement of medical research. With a strong focus on drug development and various therapeutic areas, we offer comprehensive trial design solutions that empower our clients to make informed decisions with confidence.
At Geistek Pharmaceuticals, we provide a wide range of support services tailored to meet the unique needs of our clients. Our team of industry-leading professionals excels in statistical consulting, data integration and standardization, adaptive and Bayesian designs, independent data monitoring committees, specialized medical device trials, and regulatory submission support. We are committed to delivering cost-effective solutions that prioritize accuracy, efficiency, and compliance with regulatory standards.
With a global team of over 300 experts, including renowned statisticians and regulatory compliance specialists, Geistek Pharmaceuticals ensures that every aspect of your clinical trial is meticulously addressed. Our dedication to delivering excellence is reflected in our successful track record of converting trials and meeting regulatory requirements. Trust Geistek Pharmaceuticals to be your strategic partner in driving the success of your clinical trials through innovation, expertise, and unwavering commitment to advancing medical research.
Geistek Pharmaceuticals is dedicated to providing high-quality data that empowers informed decision-making throughout clinical trials. We prioritize fast delivery of meaningful data, enabling timely and well-informed decisions while ensuring patient safety and reliable trial results. With our flexible and customized solutions, sponsors rely on our expertise, technical proficiency, and commitment to project success aligned with study goals.
Our comprehensive range of services includes statistical consulting, data integration, standards compliance, clinical systems management, and electronic data capture (EDC) database build. Leveraging our proprietary technology and innovative platforms, we automate manual processes, leading to significant time and cost savings, streamlined documentation, and improved data quality. Our focus on efficient communication, accountability, and adherence to global data and reporting requirements ensures projects stay on track, on time, and within budget.
Geistek Pharmaceuticals excels in EDC database build, offering rapid and effective completion to support critical study milestones. We maintain rigorous control and deployment of standards, facilitate streamlined review and approval processes, and conduct interactive online review meetings. By integrating data and consolidating external vendor data sources, we enhance efficiency and eliminate the need for multiple platforms. Through applied innovation and our proprietary technology platform, ICONIK, we collect real-time data, enabling holistic data review, early identification of site trends, and effective risk mitigation strategies. Trust Geistek Pharmaceuticals for our experience, expertise, and commitment to success in clinical trials.
Geistek Pharmaceuticals brings extensive experience and expertise to guide sponsors through the process of decentralized clinical trials. We understand the importance of putting the patient at the center of trial design to improve recruitment, retention, and diversity. With a tailored approach, we help assess study suitability and choose the right service options, technology, and framework to increase efficiency and maximize results.
Our solutions offer several benefits to your study. Firstly, we enhance patient recruitment and enrollment rates by expanding geographical outreach and utilizing digital health technologies. This makes it easier for patients to participate and increases accessibility. Secondly, we prioritize an improved patient experience, focusing on retention and compliance throughout the clinical trial journey. Through personalized support services, we connect, monitor, and engage patients at every step. Lastly, our approach enables increased access to diverse patient populations and under-represented communities by removing barriers and employing digital patient recruitment strategies.
We also emphasize the importance of data quality and risk reduction. By collecting real-time data directly from the source, we reduce data variability and ensure higher quality. Our risk management and quality assurance frameworks further strengthen data integrity. Additionally, we provide centralized remote monitoring and data analytics capabilities, enabling real-time detection and response to data anomalies. Geistek Pharmaceuticals is committed to guiding sponsors through decentralized clinical trials, offering expertise and solutions that drive better outcomes and patient-centric trial experiences.
Geistek Pharmaceuticals is committed to delivering better clinical trial outcomes by providing clinically relevant data through Endpoint Adjudication. We understand the importance of minimizing variation in important trial outcome events and ensuring consistent reporting across regions. Our adaptable and client-oriented team has developed efficient processes to achieve successful results.
With established relationships with over 250 experts and key opinion leaders worldwide, we have access to a wealth of therapeutic, clinical research, and endpoint adjudication expertise. We offer a range of services, including contracting adjudication committee members, coordinating committee meetings, developing endpoint reporting forms, and creating project-specific process flows. Our experienced team, led by a management team with 40 years of endpoint adjudication experience, ensures that all endpoints are processed efficiently with clinically relevant data.
At Geistek Pharmaceuticals, we employ innovative and reliable technology to support Endpoint Adjudication. Our web-based electronic adjudication system (EAS) is compliant with 21 CFR Part 11 regulations, ensuring data integrity and complete transparency. The EAS improves workflow efficiency, provides an audit trail of activities, and offers secure access 24/7. With features such as data upload from sites, centralized storage of endpoint data, and easy exportability for analysis, our technology streamlines the adjudication process.
Geistek Pharmaceuticals specializes in comprehensive logistical solutions for clinical trials through our Global Logistics division. We understand the importance of seamless integration into your study’s operations to ensure efficient trial management.
With a team of highly trained professionals and a robust depot network, we possess the expertise to handle a wide range of clinical trial supplies, including medicinal products, medical equipment, electronic devices, and ancillary supplies. Our focus is on delivering high-quality services while adhering to industry operational standards.
Our logistics services encompass import and export processes across all phases of your clinical trial. We manage the necessary permissions, review and approve shipping documents, track shipments during international distribution, and handle customs clearance in the destination country. Our goal is to ensure smooth coordination and reliable transportation of your trial supplies.
Additionally, we offer depot and distribution services tailored to your specific needs. Our capabilities include storage of various temperature-sensitive products, additional labeling requirements, handling and distribution of investigational medical products and clinical trial materials, sourcing of comparators and concomitant medication, equipment purchase or lease, as well as proper return and disposal procedures for unused drugs.
At Geistek Pharmaceuticals, we possess the global logistics expertise to support your clinical supplies management needs effectively. Contact us today to discuss how our services can optimize your clinical trial operations.
Geistek’s Medical Affairs team plays a crucial role in supporting the clinical trial and drug development process. Their experienced physicians and clinical research professionals offer assistance in all stages of clinical trials, providing guidance on protocol design, eligibility criteria, and study assessment options.
Incorporating innovative solutions, Geistek utilizes the Geistek Medical Data Review (MDR) application, enabling real-time analysis of medical data for accurate and efficient medical and safety oversight during trials. They also prioritize direct communication by conducting face-to-face protocol discussions with Principal Investigators and on-site visits to enhance study enrollment.
With a global presence and a diverse range of therapeutic expertise, Geistek’s Medical Affairs team provides comprehensive medical monitoring services. Their offerings include medical management, protocol review, patient safety assessment, medical data analysis, safety signal identification, and Clinical Study Report (CSR) generation. Geistek’s extensive knowledge and experience across various therapeutic areas ensure effective support throughout the clinical trial process.
Overall, Geistek’s Medical Affairs team delivers valuable support to optimize the clinical trial and drug development journey. Through their expertise in protocol design, utilization of innovative medical data review technology, and global medical monitoring services, Geistek empowers researchers to conduct successful trials in diverse therapeutic fields.
Geistek Pharmaceuticals offers comprehensive Medical Writing & Publishing services to support the pharmaceutical industry in generating high-quality scientific documents. Their experienced team collaborates closely with researchers and sponsors to deliver accurate, clear, and compliant content for a variety of documents, including protocols, reports, manuscripts, and regulatory submissions.
With a deep understanding of regulatory requirements and therapeutic areas, Geistek’s medical writers possess the expertise to effectively interpret and communicate complex clinical data. Their specialized knowledge allows them to tailor solutions for each project, ensuring accuracy and clarity in the final documents.
Geistek Pharmaceuticals emphasizes timely delivery and adherence to project timelines. Their dedicated project managers work closely with clients to establish clear milestones and ensure efficient coordination. By providing reliable and high-quality medical writing services, Geistek supports pharmaceutical companies in meeting their regulatory and publication goals.
Geistek Pharmaceuticals specializes in providing comprehensive Pharmacovigilance services to ensure the safety and monitoring of pharmaceutical products. Their team of experienced professionals is dedicated to detecting, assessing, and preventing adverse drug reactions and other safety-related issues throughout the lifecycle of the products.
Their Pharmacovigilance services encompass various activities, including the collection and analysis of adverse event reports, signal detection and management, risk assessment, and safety data management. Geistek Pharmaceuticals follows global regulatory guidelines to ensure accurate and timely reporting of safety information, prioritizing patient safety and compliance with regulatory requirements.
By partnering with Geistek Pharmaceuticals for their pharmacovigilance needs, pharmaceutical companies can rely on their expertise to monitor the safety profile of drugs, identify potential risks, and implement risk mitigation strategies. Geistek Pharmaceuticals plays a critical role in helping companies meet their regulatory obligations and maintain high standards of drug safety, ultimately ensuring the well-being of patients and promoting public health.
Geistek Pharmaceuticals provides comprehensive Regulatory Affairs services to navigate regulatory requirements and facilitate the development and commercialization of pharmaceutical products. Their expertise covers regulatory strategy, dossier preparation, labeling compliance, and post-marketing surveillance.
With a deep understanding of regional and global regulations, Geistek Pharmaceuticals helps clients navigate different markets, ensuring adherence to specific requirements and timelines. Their regulatory expertise expedites approvals, minimizes risks, and ensures compliant product launch.
Partnering with Geistek Pharmaceuticals streamlines the regulatory process, mitigates compliance risks, and maximizes successful product registration. They play a crucial role in achieving regulatory compliance and delivering safe and effective healthcare products to patients worldwide.
We are setting new standards in clinical excellence. By prioritizing meaningful metrics, we are consistently delivering economic value to our clients. Our extensive experience encompasses both small-scale studies and large, intricate multinational projects.
At Geistek Pharmaceuticals, our team of development experts leverages their expertise to ensure accessibility of products and treatments to patients through our Site & Patient Solutions. This encompasses various aspects, including utilizing patient insights for optimized trial design, engaging with patient advocacy groups, and implementing customized patient recruitment strategies.
INTRODUCTION ¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment