Learn how USDM delivered a managed service, turn-key solution that significantly reduced clinical study time and study cost.
Propel your company toward unprecedented optimization and transformation with an integrated GxP compliance approach. All while achieving the safety, efficacy, and integrity that is non-negotiable in clinical trials.
Trust USDM Life Sciences to find transformative solutions for Good Clinical Practice (GCP) with our integrated GxP compliance managed service.
Experience a comprehensive managed service approach that guides pharmaceutical and biotechnology companies in clinical operations. From Phase I trials to successful regulatory submissions, our team of experts has decades of industry experience to help make your clinical endeavors compliant with U.S. Food and Drug Administration (FDA) regulations and international regulations like the European Medicines Agency (EMA).
Achieve Clinical Trials Excellence with Integrated GxP Compliance
Clinical trials can be labor-intensive. They demand strategic planning, meticulous execution, and unwavering dedication. Get end-to-end support—including clinical user acceptance testing, validation services, data management, and regulatory submissions—with USDM’s GCP managed services. We empower your organization to accelerate timelines, optimize resources, and conduct successful clinical trials that pave the way for groundbreaking medical advancements.
Explore Managed Services Options for Clinical IT Systems
In this digital age, robust and streamlined IT systems are necessary to support efficient clinical operations. Discover solutions that integrate seamlessly into your workflows with offerings from USDM’s clinical IT systems managed services. Our experts ensure that your infrastructure uses advanced technologies to enhance data accuracy, accessibility, and security throughout the clinical trial lifecycle.
Clinical Systems Services
Save time and money with solutions offered by USDM, which include:
- Standard Operating Procedure (SOP) development
- Vendor and system evaluations, selection, and management
- System design, implementation, validation, and maintenance for:
- Electronic patient-reported outcomes (ePRO)
- Electronic document management system (EDMS)
- Electronic common technical document
- Clinical trial management system (CTMS)
- Interactive response technology (ITR)
- Interactive Voice Response System (IVRS)
- Electronic data capture (EDC)
- Electronic trial master file (eTMF)
- Clinical data warehouse
- Secure data server
- Safety database
USDM has more than 23 years of experience in the life sciences industry and has developed best practices for:
- Study-specific user acceptance testing (EDC, IVRS, and ePRO)
- Process analysis, improvement, and management
- Clinical systems integration and validation
- Clinical and investigator portals
- Vendor selection
Standardizing Your Clinical Studies
Life sciences companies have cut study startup time by more than 50% and reduced database lock time from 40 days to 14 days using USDM’s methods for standardizing clinical studies. We accomplish this by:
- Selecting a single vendor for all studies
- Defining core standards that can be used across studies
- Building and testing core study components
- Developing a process for creating study-specific designs
Choose USDM Life Sciences as Your GCP Managed Service Provider
Maintaining the highest ethical and quality standards is imperative during clinical trials. USDM’s GCP managed service approach helps to ensure that your operations align with FDA and international regulations. Our experienced consultants work closely with your team to establish comprehensive GCP-compliant processes, like investigator site training and audit preparation. By mitigating risks and upholding integrity, we enable you to navigate the regulatory landscape confidently.
Our expertise in the life sciences industry is why companies trust us to achieve cost savings during clinical trials.
- Industry expertise: Our seasoned professionals orchestrate your clinical operations and bring a wealth of knowledge and insights to your projects.
- Tailored solutions: We understand that each clinical trial is unique. Our services are customized to suit your specific needs and provide adaptable solutions for optimal results.
- Regulatory compliance: Navigating regulatory complexities is a cornerstone of our expertise. Our services ensure that you meet FDA and international requirements to safeguard your trials and submissions.
- Improved efficiency: Time and resources are precious in clinical operations. Our methodologies are designed to maximize efficiency and accelerate timelines without compromising quality.
- Rapid innovation: We stay informed of industry trends and technological advancements to help you integrate innovation into your clinical operations.
Frequently Asked Questions
GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are respected and protected.
Those who conduct the studies are required to comply with applicable laws and regulations intended to ensure the integrity of clinical data on which product approvals are based. This helps to protect the rights, safety, and welfare of human subjects.
Clinical trials of drugs and medical devices go through four phases to determine safety, effectiveness, and side effects:
- Phase 1 tests a drug or device on around 20 to 80 people.
- Phase 2 tests a drug or device on around 100 to 300 people. This phase determines whether the drug or device works on people who have a certain disease or condition.
- Phase 3 gathers information from several hundred to a few thousand people in different populations about safety and effectiveness.
- Phase 4 takes place after the FDA approves the drug or device.
A Clinical Quality Management System (CQMS) applies industry best practices to clinical processes from research through study management. It creates a framework to deliver the right outcome, mitigate and manage risk, and continually improve the process. CQMS optimization helps reduce startup time, manage study risk, and safely store results.