Our Service Sets Us Apart

Experience. Quality. And a passion for top-notch service.

As a clinical research organization serving the pharmaceutical, biotechnology and device industries for more than 15 years, ProTrials Research has built a solid reputation for excellence. Our goals are simple: to ensure that your needs are met and your study protocols successfully execute...each and every time. ProTrials professionals provide one of the industry’s highest average years of experience - you can trust us to understand your requirements, whether you hire a single staff member on a consulting basis or retain an entire team of experienced monitors in the field.

We offer a suite of services focused on clinical operations experience:

• Experience in a broad range of therapeutic areas
• Phase I-IV clinical trials
• Highly-skilled project management services
• Operational experience in North America, South America, Asia and Europe

Experience Makes a Difference

Research mistakes are costly. With team member averaging 14+ years of clinical operations experience, and the company's completion of hundreds of Phase I-IV clinical trials as a whole, ProTrials offers the comprehensive project management service that can mean the difference between your study's failure and success. In addition, our project managers have specialized tools, forms, and technology to streamline information and maintain tight timelines.

Whether you utilize ProTrials to support your in-house project team, or rely on us for a complete outsourced management solution, our professionals deliver the utmost attention to detail, from study initiation to completion. Our project managers closely interact with clinical research associates, medical monitors, data managers, statisticians and outside vendors to ensure that each study is completed on time and on budget.

Monitoring is Our Strength and Passion

At ProTrials, clinical monitoring services are flexible enough to accommodate the specific needs of your project's protocol. Experienced individuals or entire teams are available to monitor all aspects of a clinical trial, or simply to fill in the critical knowledge or experience gaps in your existing team.

Although U.S.-based, ProTrials and its team operate around the globe. Whether a clinical trial is conducted in one city or at multiple sites, locally or internationally, ProTrials has the people you need. On average, each of our CRAs has over 10 years of monitoring experience - setting a new benchmark in the industry for professionalism and competency. And, depending on each study's size and complexity, CRAs are assigned to monitor no more than two projects simultaneously, ensuring that your goals and deliverables are successfully achieved.

Flexible Data Management Solutions

Clean data, delivered in a timely manner, is critical for the successful operation of even the smallest study. ProTrials has extensive experience working with paper-based data collection systems and those utilizing either in-house legacy IT designs or the latest commercially available EDC-based tools.

We know and will work with any system you trust and already have in place. Or, through our unique partnership network, ProTrials now offers a variety of technology solutions to meet your individual project needs, and can guide you in the selection of the right methodology for your company and study.

Quality Every Step of the Way

ProTrials' quality assurance auditing services ensure the validity of your study, from initiation to data lock...and beyond. Our auditors are specialists in GCP, ICH and FDA regulations and processes, offering:

• Individual clinical investigator site audits
• A full audit of an ongoing trial, anywhere in the world
• Audits of vendors associated with your trial
• FDA preparatory audits
• Trial master file audits
• SOP audits

We maintain a dedicated Quality Assurance team with the training and experience to ensure the integrity of all study-related deliverables. In addition, ProTrials provides organizations with Quality Assurance services including co-monitoring, back-monitoring and quality assurance audits of clinical sites or competitor CROs.

When ProTrials is awarded a project, we immediately implement an internal quality program that conducts periodic audits throughout the lifetime of the study.In addition, to maintain our reputation for high levels of service and expertise, we continually conduct internal staff training on topics ranging from new FDA regulations to specific therapeutic training (e.g. ophthalmology, oncology, etc.).

Eliminating Vendor Headaches

ProTrials has extensive experience managing vendors providing ancillary clinical trial services, such as central labs, reading centers and IRBs, data management/statistics, IVRS, investigational product packaging/labeling/distribution, etc. We can help you select vendors, or select, contract and directly manage vendors for your study. Either way, ProTrials will facilitate smooth and efficient communications and interactions between all groups throughout the project lifecycle.

We're the Regulations Expert

ProTrials can provide full regulatory review and support for studies ranging in size from small, single site investigational studies to large, randomized controlled clinical trials - everything from domestic and international regulatory submissions to safety reporting. We also can just review track, and maintain your essential project related regulatory documents.

ProTrials keeps abreast of all communications from the FDA and international regulatory agencies, including new guidelines and recommendations. Within ProTrials, we train our entire staff on revised or clarified regulatory information through company newsletters and seminars; we also update our internal SOPs and guidelines using proprietary templates, which are available for purchase by sponsor companies wishing to implement or complement their company SOPs.

Round the Clock Medical Monitoring

Our medical monitor consultants are tightly integrated with your team to provide the medical support your project requires, including the following services:

• 24-hour Medical Monitoring Support
• Medical Team Representative and Expertise for Your Protocol or Program
• Protocol, Informed Consent, and CRF Design and Review
• Regulatory Advice, Counseling and Support
• Investigator Brochure Development
• Laboratory Data Review
• Medical Data/Listing Review
• Medical Coding
• Medical Writing
• Safety Review and Consulting
• Data Monitoring Committee Coordination (DMC and DSMB)
• Communication with Key Opinion Leaders

Service and Quality: Anytime, Anywhere

ProTrials Research supports and manages domestic and international clinical trial research projects that take place in North and Central America, Central and Eastern Europe, Asia and the Pacific Rim.

Our established alliance partners deliver the additional local support we may need to ensure the smooth and successful operation of every study. Each of these alliance partners has passed our rigorous criteria for excellence and offers seasoned expertise in local customs, languages and research environments. By operating from a single point of contact, we deliver the cohesive monitoring and unified quality and service our customers have come to expect from ProTrials.