Population Health Research Institute
About PHRI

Key Capabilities
Our key capabilities in the coordination of large, global, clinical trials

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 Research Activity  Our Key Capabilities

Conceptual Development & Fundraising

  • Protocol development tailored to required fundraising, i.e. protocols for government and industry funding mechanism
  • Responding to grant reviews
  • Negotiating with industry 
Study Design and Set-up, Data Management, Statistical Analysis
  • Identify most appropriate and efficient methodology
  • Assist in sample size calculations and development of analysis plan
  • Develop appropriate study framework in terms of centres, countries to be involved
  • Develop appropriate study procedures (e.g. visit content and schedule, blood collection)
  • Develop consent forms compliant with key regulatory and ethical standards internationally
  • Design case report forms
  • Provide automated randomization service
  • Design study database
 Study Initiation
  • Ensure suitability of sites through tailored feasibility questionnaires
  • Develop and implement site training both through site visits and telephone/web based training tools
  • Make regulatory applications and assist in discussions/meetings with regulatory agencies
  • Assist centres to submit for ethics approval if possible
  • Identify, collect and maintain required regulatory documents from sites internationally
  • Create and negotiate  site contracts internationally
  • Regular monitoring of recruitment and intervention when required to improve recruitment
  • Develop an efficient monitoring plan that utilizes central monitoring as well as local monitoring
 Study Maintenance
  • Regulate central monitoring for visit and medication adherence and intervention locally when required
  • Regular monitoring of data quality, feedback to sites on incorrect/missing data, local site visit if issues persist
  • Regular central monitoring focusing on key parameters that may be indicative of fraud; arrange site visits if concerns are identified
  • Safety reporting to national regulatory bodies and sites
  • Organize and conduct investigator bodies and sites
  • Organize and conduct investigator meetings
  • Ongoing quarterly payments to centres based on performance (i.e. quality of data)
 Study Close-Out
  • Rapid and efficient collection of data, resolution of queries
  • Facilitate close-out at centres (e.g. ethics notification of study close, storage of participant files, notification of study close to primary care physician)
  • Rapid database close for final analysis
  • Data analysis with verification (i.e. second review to ensure accuracy)
  • Central laboratory analysis
  • Assist in preparing presentation of final study results for public presentation
Publication and Dissemination of Study Results
  • Preparation of manuscripts (including specific journal considerations)
  • Assist/advice regarding press activities
  • Develop and facilitate publication plan outlining manuscripts beyond the main publication
  • Develop slides/presentations/educational materials
 Regulatory Submissions
  • Write the Clinical Trial Report (occasionally on our own, but generally supporting a sponsors efforts).
  • Assist with sponsor's meetings with regulatory agencies

 

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Population Health Research Institute • Hamilton, Ontario • information@phri.ca