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Good People Working on Good Projects with Good Process

Clinical Research

From the first thought of conducting a clinical trial to the final submission documents, Frestedt Incorporated’s team of knowledgeable industry professionals can help guide you through the clinical trial phases.

Preparation:

  • Feasibility Assessment: Analyze the proposed trial in relation to the study design, available study population and demographics and the proposed site selections
  • Comprehensive Literature Review: Search for published research on competitive and related products as well as past sponsor research and provide a comprehensive, unbiased report
  • Trial budgets: Develop an overall trial budget and site specific negotiation tools
  • Protocol Development: Create protocol synopses and comprehensive protocols with evaluation of trial design
  • Study Documents: Craft all documents needed for seamless execution of the clinical study
  • Investigator/Site Selection: Assist in identifying and qualifying investigators and sites with the correct combination of background and experience in your therapeutic area and clinical research
  • Sponsor/CRO Training: Conduct on-site or virtual training for internal or external personnel on any facet of clinical research and/or the specific trial

Initiation:

  • Site Personnel Training: Conduct on-site or virtual training for internal or external personnel on any facet of clinical research and/or the specific trial
  • IRB Submissions: Evaluate IRB turn around, submit and track approvals
  • Site Activation: Initiate activation process for each site upon IRB approvals
  • Trial Registration: Facilitate registration of the trial including account creation if necessary on www.clinicaltrials.gov

Conduct:

  • Site Management: Conduct research operations at medical provider site and manage all aspects of study activities
  • Monitoring: Visit research sites per the approved monitoring plan to evaluate CRF documentation versus source documents and well as protocol compliance
  • Data Management/Biostatistics: Assist in management of trial data and biostatistical analysis
  • AE Reporting and Analysis: Aid in submission of required AE reporting and conduct analysis of reported events

Close-Out:

  • Study Close-out: Conduct activities related to site closures and obtain all final study documentation
  • Final Study Report: Compile all study documentation, analyze and provide a comprehensive written report specific to the protocol outcome measures

Cycle 5 – Joy Frestedt from MAPS Medical Pain Clinics on Vimeo.

Many of our trials are conducted at (MAPS Applied Research Center) MARC.
 
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