MEDICAL/REGULATORY AFFAIRS - Medical affairs encompasses pharmacovigilance, strategic consulting, and medical oversight of all phases of clinical research. Our Medical Directors contribute scientific expertise across a broad range of therapeutic areas throughout the product life cycle. Our pharmacovigilance services group utilizes the Oracle Adverse Event Reporting System (AERS) which is powerful drug safety platform for individual case management, analysis, and report preparation. We can either supplement your in-house medical staff or serve as client representatives at investigator meetings and regulatory presentations.

Radiant Development offers 24-hour medical coverage for safety monitoring, and prepares IND safety reports and narratives. In addition, we can create or participate in data safety monitoring boards.

Regulatory input is a critical area for product development. Radiant Development can assist with regulatory strategy as well as preparation of submissions such as IND, NDA, IDE, 505b(2), nutrition and dietary supplement applications, annual reports and safety reports.

FEASIBILITY ANALYSIS - A feasibility analysis is developed to ensure that your project plan is designed for success. Radiant Development is able to provide instant feedback from Radiant investigative sites and Radiant Recruitment's historical metrics database. Additionally, we will extend beyond Radiant Research sites to canvas qualified sites within our investigator database to obtain their feedback regarding feasibility.

I NVESTIGATOR SELECTION - With experience in every major therapeutic area, Radiant Development has access to investigative sites, which can ensure rapid study start-up and completion across a broad range of indications. In addition to Radiant sites, we maintain an extensive database of top investigators and sites with proven track records.

PATIENT RECRUITMENT - Radiant has spent the last 15 years building the most sophisticated participant recruitment process in the industry. With a 30-seat call center, on-staff Media Buyers and Graphic Designers dedicated to clinical trial recruitment, we can create and execute a recruitment plan tailored to your study design. We know what works.

PROJECT MANAGEMENT - Our Project Managers have strong clinical backgrounds and their expertise facilitates the management and oversight of all aspects of clinical trial management. Our Project Managers interact directly with our Clinical and Medical Monitors, Data Managers, Biostatisticians and Medical Writing personnel to ensure the effective and timely completion of the study. The Project Manager ensures that the study is completed on time, on budget, and with the highest level of quality. Our goal is to exceed your expectations.

CLINICAL MONITORING - All Radiant Development clinical monitoring activities are conducted according to our Standard Operating Procedures, which are compliant with ICH and GCP guidelines. Our monitoring force is flexible, scalable and can accommodate the needs of our clients. We can staff a large Phase III trial, and also give the smaller Phase II trial the attention it requires. Our Clinical Research Associate (CRA) Managers oversee all CRAs and interface with the Project Teams to ensure optimal resource allocation.

DATA MANAGEMENT - Radiant Development's EDC solution combines a web-based platform with our data management services. The system is fully validated and is 21 CFR Part 11 compliant.

For clients who prefer paper case report form completion, we use our clinical data management system to perform double-data entry, electronic data edit checks, quality control and quality assurance processes. Our clinical data management system is fully validated.

NUTRIENT ANALYSIS - Radiant Development has expertise in providing nutrient analysis for research trials. Our staff has played a pivotal role in most of the health claims for functional foods. We employ several Registered Dieticians who are experts in the field of nutrition research.

BIOSTATISTICS - Radiant Development provides comprehensive statistical support to clients, from protocol development to regulatory submission. Our statisticians are assigned as part of the project team to address sample size, methodology and generation of the statistical analysis plan. We have represented sponsors in statistical meetings with the FDA and other regulatory agencies.

MEDICAL WRITING - Radiant Development's Medical Writing team offers doctoral level scientific expertise. We provide submission ready documents across all areas of pre and post marketing clinical development.

QUALITY ASSURANCE - Radiant Development's Quality Assurance Department is American Society of Quality (ASQ) certified, with 20 years of direct GXP pharmaceutical, biologics and device experience. Our QA department has both US and International auditing experience.