Clinical Trial Conduct and Study Management Services

Investigational Medicinal Products (IMPs) and Medical Devices

Research Professionals - CRO Clinical Trial Conduct Services
Clinical trials utilize human subjects to evaluate the safety and effectiveness of medical, surgical, or behavioral interventions. Conducting these clinical trials involves a wide range of activities that must be highly coordinated with attention to detail in order to provide high quality data. Research Professionals CRO offers industry leading clinical trial conduct services throughout the study’s duration to deliver accurate and reliable results to sponsor customers including:

Three Research Professionals CRO medical staff in blue scrubs review subject medical results in clinical setting.

Clinical Trial Management Services
Successfully managing clinical trials to customer expectations is always our core focus. We plan and implement clinical trial management plans that deliver results on time and to budget. Research Professionals CRO manages studies to meet current regulatory and quality standards while following best practices. Providing strong project management combined with continuous and open communication between all involved parties helps to keep customer clinical trials on track. Research Professionals offers complete GCP CRO capabilities performed by experienced and knowledgeable staff that drive your study to completion with confidence.

Clinical Trial Site Monitoring Activities
Our highly trained and experienced Clinical Research Associates (CRAs) work alongside our study teams engage to conduct a wide range of clinical trial management activities that support effective and efficient site monitoring. We are well versed in Clinical Trials Directive (2001/20/EC), EU Clinical Trials Regulation (536/2014), and Medical Device Regulation (2017/745 EU MDR) and comply with the most current forms of these regulations in the clinical trial we manage. Research Professionals works within Good Clinical Practice (ICH GCP E6 R2) requirements which is built into our processes, procedures, SOPs, and training. As a leading CRO we work proactively only with Principal Investigators (PIs) that are ideally qualified and fully trained to conduct each clinical trial. When a study protocol needs to be modified at any point, our experienced staff can help to make sure changes are smoothly implemented, minimizing the impact on clinical trial conduct. A primary objective for our CRAs is to ensure that the studies they manage for customers stay on track and remain compliant. Our clinical trial site monitoring services include the following:

  • Liaise with Principal Investigators regarding trial conduct
  • Train the clinical trial staff in study specific processes (per protocol), GCPs and applicable standard operating procedures (SOPs) per relevant regulatory requirements
  • Manage all clinical trial documents and records outlined in the ICH Guidelines for Good Clinical Practice (GCP) to maintain an inspection-ready Trial Master File (TMF) throughout the conduct of the study
  • Deploy Interactive Response Technology (IRT) to randomize patients and manage drug supplies for clinical trials
  • Initiate the clinical trial sites and ensure that clinical trial materials, drug/investigational medicinal product or medical device, are available on site for study conduct and are tracked according to regulations
  • Utilize a Clinical Trial Management System (CTMS) that supports customer clinical trials with a single centralized web-based resource
  • Monitor the clinical trial monitoring visits, site monitoring visits, interim monitoring visits and close-out visits for the duration of the study
  • Review Informed Consent Forms (ICF), Case Report Forms (CRF), investigational drug accountability, and Adverse Events (AE) reporting for errors and compliance
  • Complete document management services including filing/collecting trial documentation and reports
  • Oversee clinical trial conduct in support of quality and compliance requirements
  • Manage all scheduling of clinical project team and study meetings, including clinical trial site, Key Opinion Leader (KOL), and consultant meetings
  • Supporting the analysis, summary, and reporting of clinical data throughout the study
  • Reviewing Serious Adverse Events (SAE), and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks

Research Professionals CRO emphasizes using critical data and processes to improve the efficiency of monitoring studies. We regularly assess quality, timeline, and cost data so that we can continuously improve our clinical trial management services and the results we provide to customers.

Research Professionals CRO clinical researcher in white lab coat uses digital tablet to assess clinical study data.

Regulatory Management Services
Research Professionals CRO provides comprehensive support for the management of regulatory submission activities for Phase 1 - Phase 2 - Phase 3 - Phase 4 clinical trials for Investigational Medicinal Products (IMPs) and Medical Devices. Our dedicated staff apply their years of experience to the preparation, writing, and filing of customer regulatory submissions with regulatory authorities. Research Professionals CRO has a strong understanding of the requirements of both local and central Ethical Committees (EC) in the countries in which we operate. The resulting efficient and timely ethics committee review process means lengthy ethics review delays are less likely, keeping the study timeline on track. Regulatory management is a core focus at Research Professionals CRO with supporting services including:

Vendor Management

Vendor management can be time-consuming responsibility when it comes to managing clinical trials. Research Professionals CRO takes on these responsibilities and manages them throughout the duration of the clinical trial. From central labs, data services, to pharmacovigilance, we cover your all of your vendor management needs. We monitor the timeliness and quality of the vendors working on the study, and well as their compliance with maintaining the agreed budget and contract terms, holding them to the same standards you would. From invoice review and verification to responding to vendor questions about the study, Research Professionals CRO is your complete clinical trial vendor management partner.

A central laboratory centrifuges clinical study subject blood samples as part of an RP-CRO clinical study.

Research Professionals Subject Travel Expense Reimbursement Services

Subject cars driving on a tree lined European street to Research Professionals CRO clinical sites for a clinical trial.

Research Professionals CRO keeps on top of patient expense reimbursement throughout the entire clinical trial conduct. We reimburse all validated expenses related to subject study visits per the specific clinical trial protocol and subject agreement terms promptly. We have extensive knowledge regarding local taxation rules related to subject travel expenses and ensure that all reimbursements are compliant. When you are dealing with directly subjects, confidentiality is always a priority and RP-CRO are well versed in these requirements. We protect subject privacy by handling all personal data according to current privacy and clinical regulations, use anonymized data where required and perform GDPR compliant data protection oversight provided by an appointed Data Protection Officer. Research Professionals are focused not only on managing your clinical trials, but also attending to clinical study administrative tasks so you can focus on the bigger picture.

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