An important factor of clinical trials is clinical trial site monitoring. The American College of Regenerative Medicine 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. The American College of Regenerative Medicine offers the following services:

Clinical Trial & Manufacturing Budget Preparation

Our strategic advisory teams help our members 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.

We offer 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.

The American College of Regenerative Medicine 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 specialists, pulmonologists, spinal cord injury experts and statisticians.

We offer 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, The American College of Regenerative Medicine 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. Our team members are experts in creating realistic timelines, making a schedule that ensures you achieve all approvals and certificates on-time.

At The American College of Regenerative Medicine, we understand each sponsor 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.

We offer the following services:

• Trial Database Creation & Validation

• Data Validation Procedures Implementation

• Trial Site Data Input and Entry Monitoring

• Data Processing & Analysis

Medical Monitoring Management

The American College of Regenerative Medicine 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, outlined 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. The American College of Regenerative Medicine will help develop the best plan for your organization and trial, providing the appropriate oversight and monitoring for patient safety and welfare.