PROTOCOL DESIGN
Our approach to protocol development integrates sponsor objectives directly into a compliant regulatory framework. We work with your team to understand the unique qualities of your technology and its intended use. This vital input is then structured within the rigorous context of international guidance documents and standards (such as Declaration of Helsinki, ISO 14155, 21 CFR Part 50 – Protection of Human Subjects, and Internation Conference of Harmonization E6 Good Clinical Practice Guidelines), ensuring the final protocol is not only scientifically robust but also purpose-built to meet established regulatory and ethical benchmarks.
IRB MANAGEMENT
Participant safety and ethical conduct are paramount, and our IRB management process reflects this commitment ensuring rigorous ethical oversight for every study. Our team prepares and submits all necessary documentation, including the protocol, Informed Consent Form (ICF), recruitment materials, and investigator qualifications.
We act as the primary liaison with the IRB, managing all communications, proactively address potential queries, work diligently to secure timely approval, handling subsequent amendments, continuing reviews, and investigator reports to maintain compliance throughout the entire lifecycle of the trial.
REGULATORY DOCUMENTATION
We provide comprehensive preparation and maintenance of all essential regulatory documentation. Our detailed Standard Operating Procedures (SOPs) dictate every step of the process, from the initial creation of source documents to the final compilation of the Trial Master File (TMF). This disciplined approach ensures that all regulatory files are consistently organized, complete, and inspection ready.
Our services include a detailed monitoring plan based on our SOPs, which our Monitors follow through Source Data Verification (SDV) and compliance checks at the site. The findings from these monitoring activities are documented and integrated into the TMF, creating a continuous cycle of quality control where our compliant regulatory files are a direct reflection of a well-monitored study.
CRFs, ICFs, and HEALTH FORMS
We provide expert design and development of all critical study documents, including protocol-specific Case Report Forms (CRFs), clear and compliant Informed Consent Forms (ICFs), and tailored Health History Forms. This ensures site staff can capture accurate and compliant data with ease.
Our expertise is complemented by our technical proficiency across multiple Electronic Data Capture (EDC) platforms, allowing us to seamlessly manage your study within your preferred system or recommend the best fit for your trial's needs.
DATA COLLECTION
Our data collection methodology is designed to ensure every data point is accurate, complete, and timely. Accuracy is achieved through methodically designed data collection forms, gold-standard reference methods, and rigorous Source Data Verification (SDV) by our Clinical Monitors. We deliver a clean final dataset in the most efficient timeframe possible.
Beyond their professional qualifications, every staff member is thoroughly trained on the specific nuances of the protocol and your technology before a study begins. This dedicated, study-specific preparation ensures strict protocol adherence, consistency across all activities, and the highest quality of data collection.
DATA ANALYSIS
Our data analysis process is methodical and transparent, beginning a collaboratively developed Statistical Analysis Plan (SAP) that is aligned to regulatory standards. We execute on this plan to conduct both interim and final analyses, if needed. Our team then authors a comprehensive, FDA-ready report that logically presents the methodology, data, and conclusions, ensuring the final submission package is complete and built to withstand rigorous regulatory scrutiny.
DEDICATED MONITORING SERVICES
We employ a strategic Risk-Based Monitoring (RBM) approach in accordance with ICH E6(R2) guidelines to optimize trial oversight. Our Monitors concentrate on verifying the informed consent process, complete documentation, and ensuring the primary endpoint data is clean and accurate. We ensue rigorous oversight and compliance while maintaining maximum efficiency.