RP-CRO Clinical Trial Start-up Services

Clinical Research Feasibility, Budget Development, Contract negotiation

Research Professionals CRO takes the start of every clinical trial seriously. We perform a complete clinical research feasibility study to make sure the trial can be successfully implemented and can meet regulatory requirements. Then RP-CRO develops the required study documents, develops the clinical research study protocol, and determines the associated biostatistical models needed to analyze the data. Our clinical research experts also support vendor and site selection, taking care that site budgets are carefully planned, and contracts are reliably managed to customer expectations. All these elements are essential to an efficient starting point for every customer research study.

Research Professionals CRO Clinical Research Study Start-Up Services

  1. Clinical research feasibility assessment
  2. Start-up regulatory requirements evaluation
  3. Development of clinical research study related documents
  4. Biostatistics and clinical research study protocol design
  5. Vendor Selection & Management
  6. Clinical site selection and qualification
  7. Clinical site budget and contract management

Male doctor in white lab coat sharing medical record with nurse in blue scrubs in clinic hallway for clinical start-up.

Clinical Trial Feasibility Assessment
At Research Professionals CRO we have optimized our clinical research study intake process so that sponsors can begin their trials as quickly as possible. We assess incoming clinical trials for required operational capabilities, trial budgeting and staff resources to create a comprehensive clinical research study plan. We incorporate a site placement strategy and study lead reviews to ensure the study is conducted at the right sites with right clinical staff. We design and support the completion of Feasibility Questionnaires (FQs) to ensure site capabilities meet the study’s requirements and evaluate the resulting FQ data in feasibility meetings with customers. Research Professionals CRO conducts in-person Site Qualification Visits (SQVs) in order to identify appropriate clinical research sites with both the capabilities and patient pools required to meet the requirements of the study protocol. These in-depth clinical trial feasibility reviews give the Principal Investigators (PIs) an opportunity to approve the studies they will run and determine if they can draw a large enough subject pool to enroll in the study. These early steps are critical to the conduct of an efficient and compliant clinical research study.

Clinical Research Regulatory Requirements Start-up Evaluation
Right from the start, our professional clinical research teams assess incoming studies for potential regulatory challenges. We design sponsor study management plans to address the many regulatory considerations of today’s Phase 1 - Phase 2 - Phase 3 - Phase 4 clinical trials or medical device studies. Research Professionals CRO plans, supports, and oversees any regulatory inspections required by the clinical research study. We always keep our clinical study regulation knowledge current along, with an up to date understanding of how new legislation will impact how we perform our clinical research study management services, so that our practices are always compliant and supportable. From the earliest stages of a clinical research study process we prepare the regulatory submissions that will be provided to regulators and ethics committees with an attention to detail. Research Professionals CRO makes compliance with the current regulatory and legislative requirements a top priority throughout, which continues throughout the course of all clinical trials or medical device studies.

Development of Clinical Research Study Related Documents
Research Professionals works closely with customers to develop the study-related documents required for the clinical trial. Our highly experienced and knowledgeable staff quickly develop and optimize a full array of clinical research documents, supporting studies at all stages including:

Biostatistics and Clinical Research Study Protocol Design
Every clinical study is part of a larger product development program. The data generated needs to be organized into a format that helps provide a clear, data-driven pathway to decision points without delay. We help our clinical research customers determine appropriate sample size calculations, incorporate design decisions, plan the analysis process, and manage its execution. A thorough biostatistical analysis combined with a strong protocol design can help provide supportable data for decision making by the sponsor and is also accepted by the regulator. Research Professionals CRO applies their extensive clinical study management experience and up to date regulatory knowledge to help sponsors design robust biostatistics plans and protocol designs.

Open RP-CRO laptop on desk with pen and notepad showing clinical research start-up data on screen for biostatistics analysis.

Clinical Research Vendor Selection & Management
Vendor management is a critical but time-consuming part of the beginning of every clinical study management program. Vendor selection, contract negotiations, and project management activities are early administrative responsibilities that are needed to start clinical research studies. Research Professionals’ experienced and cost sensitive vendor management staff shoulder the burden of this administrative responsibility for our sponsors. Our objective is to monitor timeliness and quality deliverables from a range of different subcontractors, so you don’t have to. Research Professionals CRO staff makes it worry free, so you can focus on advancing your product to patients faster. And it’s not just during study start-up. We manage vendors throughout the research study conduct and beyond to ensure a consistent and simple result for each study sponsor organization.

Site Budget and Contract Management
Research Professionals CRO leverages its strong relationships with the best clinical research specialists to accelerate the start of your important clinical trial. Our staff develop realistic site budgets based on their extensive experience that minimize major changes to your budget throughout the study conduct. We use well established, standardized contract templates for both legal and financial terms in site negotiations so we can reach agreement faster. Research Professionals’ contract managers streamline the contracting process for you by:

Research Professionals Clinical Trial Start-Up Services Excellence
Our clinical research experts engage with customers early, to ensure their study is built on a solid foundation of quality and clinical expertise. Research Professionals’ clinical trial start-up services put all the complex pieces needed for your study in place so that your clinical research study starts without delay. We take care during study start-up so that you can confidently focus on advancing your product to market and the patients that need it most.

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