Other services
How can DELPHINIUM assist you?
DELPHINIUM offers full service, from assisting in study design and protocol development until the delivery of the clinical study report.
During clinical execution several other services involved will be outsourced. Key parties are, Monitoring, Safety lab, Bioanalysis (PK/PD) and Data Management.
Based on the requirements of the clinical trial and preference of the Sponsor, an adequate partner will be contracted.
Data Management Services
At DELPHINIUM we use ClinSpark to streamline data collection and management through eSource solutions. This bedside direct entry method enhances the efficiency, accuracy, and integrity of data entry for clinical trials. Our experienced and dedicated team ensures smooth data flow and timely delivery of clean, analysis-ready datasets, by performing rigorous quality checks and real-time data cleaning. This significantly reduces the time between last-subject-last-visit and database lock.
We work only with excellent Clinical Data Management vendors to ensure clinical trial data is handled efficiently from database design to final data lock.
Together we offer comprehensive services, including Case Report Form (CRF) design, database setup, data validation, discrepancy management, and adverse event coding according to MedDRA and WHO Drug standards.
Medical Writing
From protocol development to Clinical Study Report submission, DELPHINIUM provides reliable and regulatory compliant medical writing to guide your clinical trial every step of the way. Our vendors are specialized in creating essential trial documents, including clinical study protocols, Investigator Brochures , Investigational Medicinal Product Dossiers, Informed Consent Forms, and comprehensive participant materials, ensuring full compliance with regulatory requirements.
With a focus on precision and regulatory alignment, we help streamline the documentation process, ensuring that your trial progresses smoothly from start to finish.
Bioanalytical Services
At DELPHINIUM, we offer bioanalytical, pharmacokinetic (PK), and pharmacodynamic (PD) analysis services through a network of carefully selected, trusted vendors. These vendors are chosen for their expertise in bioanalytics and their ability to align with your clinical trial timeline, minimizing the risk of shipment delays and ensuring the safe handling of your valued samples. This approach guarantees timely, accurate, and reliable bioanalytical data, supporting the success of your clinical trial.
Monitoring
During the execution of a Phase I clinical study, our preferred vendor for monitoring and site management is Research Drive.
With over 20 years of experience in Phase I and Phase II monitoring and management, Research Drive serves as your independent partner, ensuring oversight during your clinical trial with the aim of establishing a preliminary evaluation of safety.
Research Drive have experience with (complex) study designs including but not limited to pharmacokinetic/pharmacodynamic, ADME, DDI, First in human, SAD/MAD, Food effect other trial designs in healthy subjects or patients.
Research Drive trains CRAs in Phase I through a comprehensive internal 3-month CRA traineeship.
Biostatistics and PK/PD Statistics
At DELPHINIUM, our biostatistics, pharmacokinetic (PK) and pharmacodynamic (PD) statistics services are delivered in collaboration with experienced partners, carefully chosen to meet the specific requirements of your clinical trial. There is a close collaboration with the Data Management team to ensure seamless data integration, allowing for accurate and efficient analysis. This coordinated approach helps minimize delays, ensures data quality, and delivers reliable insights. With our collaborative efforts, you can trust that your statistical needs will be addressed with precision, supporting the smooth execution of your clinical trial.
Pharmacovigilance
We offer a full suite of pharmacovigilance services tailored to meet the unique needs of Phase I clinical trials, including Serious Adverse Event (SAE) reporting. Our thorough documentation and reporting processes ensure participant safety and regulatory compliance. We adhere to all relevant regulations and guidelines, guaranteeing accurate and timely reporting of safety data to regulatory authorities.
Through our selected vendors, we provide access to a European Union Qualified Person (QP) to ensuring compliance with EU pharmacovigilance regulations.
With DELPHINIUM’s pharmacovigilance services, you can trust that the safety of your trial participants is our top priority, while maintaining compliance with all regulatory requirements.
