Partners
At Research Drive, we collaborate with a select group of specialized vendors, each renowned for their expertise in supporting clinical trials at every stage.
Our Partners
From the start of your study to the final Clinical Study Report (CSR), our partners provide services designed to meet the highest standards of quality, regulatory compliance, and efficiency. We prioritize seamless integration and communication, ensuring your clinical programs benefit from flexible, adaptive, and high-quality solutions tailored to your needs.
Phase I Clinic
DELPHINIUM is a company of experienced professionals dedicated to Phase I clinical trials. With a 12-bed clinic specializing in studies with healthy volunteers, their mission is to deliver high-quality, customized Phase I clinical studies. They prioritize efficient and direct communication between sponsors and researchers, enabling a flexible, fast, and adaptive approach to clinical programs.
Medical writing
Our specialized partners offer reliable and regulatory-compliant medical writing from protocol development to Clinical Study Report submission. Our specialized partners create essential trial documents, such as Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, participant materials, and Investigational Medicinal Product Dossiers, all fully aligned with regulatory standards. By focusing on accuracy and regulatory compliance, we help streamline the documentation process, ensuring the seamless progression of your trial from start to finish.
Data Management
We collaborate exclusively with excellent Clinical Data Management partners to ensure the efficient handling of clinical trial data, from database design to final data lock. In partnership, we provide a full range of services, including database setup, Case Report Form (CRF) design, data validation, adverse event coding in accordance with MedDRA and WHO Drug standards, and discrepancy resolution.
Pharmacovigilance
Our vendor’s pharmacovigilance services are designed to meet the specific needs of clinical trials. Their robust documentation and reporting processes prioritize participant safety while ensuring full regulatory compliance. We strictly follow all relevant regulations and guidelines to guarantee the accurate and timely submission of safety data to regulatory authorities. Through our trusted partners, we offer access to a European Union Qualified Person (QP) to ensure compliance with European Union (EU) pharmacovigilance regulations. You can rely on our partners to prioritize the safety of your trial participants while ensuring adherence to all regulatory standards.
Biostatistics and PK/PD statistics
The biostatistics, pharmacokinetic (PK), and pharmacodynamic (PD) statistical services are provided in partnership with experienced vendors, selected to meet the unique needs of your clinical trial. The statistics partners work closely with the Data Management team to ensure seamless data integration, enabling efficient and accurate analysis. This coordinated approach delivers reliable insights, maintains data quality, and minimizes delays. Through our collaborative efforts, we ensure that your statistical needs are met with precision, supporting the successful execution of your clinical trial.
Bioanalytical Services
Our carefully selected vendors provide bioanalytical, PK, and PD analysis services. The vendors are chosen for their specialized expertise in bioanalytic and their capacity to meet your clinical trial timelines, ensuring the secure handling of your samples and reducing the risk of delays. This approach provides the delivery of accurate, reliable, and timely bioanalytical data, contributing to the success of your clinical trial.
Testimonials
Read our client testimonials about their experiences on working together with Research Drive.