Clinical Trial Monitoring (CRO)
An important factor of clinical trials is clinical trial site monitoring. At AssureImmune, our experts ensure your clinical trials are seamless and compliant, following all regulatory authority rules and regulations, protocol and good clinical practices.
There are several components within clinical trial monitoring, all necessary and important. AssureImmune offers the following services:
Clinical Trial & Manufacturing Budget Preparation
At AssureImmune, our strategic advisory teams help our clients establish systematic and seamless budget preparation. We work with you to save you time and money, focusing on regulatory requirements and R&D, leading to faster product development.
AssureImmune offers the following services:
- Project Integration
- Manufacturing Processes Development Integration
- Timeline & Budget Development
- Contract Negotiations
DSMB Formation & Management
The Data and Safety Monitoring Board (DSMB) is an independent group of experts who advise clinical trial sponsors and principal investigators (PI) for patient safety and welfare evaluation.
AssureImmune works with leading experts in all fields, including but not limited to cellular therapeutic specialists, immunologists, cardiologists, dermatologists, emergency medicine, endocrinologists, gastroenterologists, gynecologists, infectious disease, neurologists, oncologists, ophthalmologists, pain management, pulmonologists, spinal cord injury and statisticians.
AssureImmune offers the following DSMB services:
- DSMB Charter Preparation
- Interim/Cumulative Study-Related Adverse Events Data Review
- Interim/Cumulative Pre-Established Statistical Guideline Data
- Data Quality & Timeline Review
- Individual Site Performance Review
- Recruitment & Retention Compliance Goal Review (including women and minority participation)
- Protocol Adherence Review
- Potential Confidentiality Outcomes Review (protocol violations, unmasking)
- Safety Protocol Modifications Review
- Suspension or Early Termination Review
- Corrective Action Review
- Adverse Event Reporting Preparation
- Serious Adverse Event Reporting Preparation
- DSMB Meeting Planning/Organization
- DSMB Report Preparation
Project Management
Our experienced consultants and project management experts help companies around the world stay abreast of current quality and management guidelines. From schedules to budgets to regulatory documents, AssureImmune is with you every step of the way.
Our regulatory compliance project management team assists you in completing and submitting relevant regulatory documents, ensuring your project achieves full regulatory compliance in a fast, cost-effective manner.
Project timelines and schedules can be daunting. The AssureImmune team are experts in creating realistic timelines, making a schedule that ensures you achieve all approvals and certificates on-time.
At AssureImmune, we understand each client is different. That’s why we create a personalized project management program that’s tailored to you and your organization.
We also conduct a thorough GAP analysis, assessing your performance and ensuring your requirements and/or objectives are met.
Database Management
Our team of technical experts have years of experience in database management and works with your organization to develop your own personalized trials data management plan. This data management plan outlines how your data is managed and stored, as well as handled and protected during and after project completion.
AssureImmune offers the following services:
- Trial Database Creation & Validation
- Data Validation Procedures Implementation
- Trial Site Data Input and Entry Monitoring
- Data Processing & Analysis
Medical Monitoring Management
AssureImmune works with highly qualified medical professionals who help you develop and monitor your medical monitoring plan. Our team oversees your clinical study, ensuring it is conducted, recorded and reported in compliance with all applicable regulations.
These monitoring activities, outline in your plan, identify any deficiencies in trial conduct that may require corrective or preventative actions (CAPA), ensuring patient safety throughout your clinical trial.
Our Medical Monitoring Plan includes:
- Site procedures, including site-feasibility and initiation, site monitoring visits and site close-outs.
- Protocols for handling deviations, noncompliance, adverse events (AE) and serious adverse events reporting (SAE).
- Trials risk assessment outline and operational processes identification that require monitoring based on objective, design, study population and complexity of your trial.
- A dedicated team of highly qualified medical professionals and associates capable of serving as your trial medical monitor.
Safety Monitoring Management
Ensuring patient care and well-being is an important part of any clinical trial. At AssureImmune, our team develops the best plan for your organization and trial, providing the appropriate oversight and monitoring for patient safety and welfare.