GLOBAL HEALTH | GLOBAL PARTNERSHIPS | GLOBAL IMPACT

Our Approach

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PHRI’s goal is to answer clinically important questions and do so with the highest degree of scientific integrity and reliability. Our extensive experience has taught us that the most efficient and effective way to do this is by managing all of the key aspects of a study as one comprehensive whole, in collaboration with the sponsor (if appropriate) and a carefully selected Steering Committee. This includes playing a key role in designing the research program; leading, coordinating and conducting the trial, managing and analyzing the collected data and publishing and disseminating the findings.

As a scientific and operational project office and coordinating centre, PHRI has the necessary complement of expertise and resources, capabilities and leading edge infrastructure s to efficiently lead and conduct international, large-scale clinical outcomes trials (with more than 1 million study participants recruited). Typically, the Principal Investigators design the study and develop or consult on the protocol with the support of highly experienced biostatisticians, methodologists and an extensive network of international scientific expert collaborators. They then work closely with the study team to select, set-up and manage the clinical sites; track and study drug logistics; and review the accruing data. Moreover PHRI has developed a network of proven National Leaders who select and recruit appropriate investigator sites and provide local scientific expertise and medical leadership as the study progresses. This network of experts, (1500 sites in 86 countries) provides strength and stability to our global infrastructure.

Scientific Integrity and Reliability starts with:

  • Stringent Protocol development to maintain scientific rigor
  • Novel and clinically relevant study design
  • Statistical expertise to design an adequately powered study
  • Rigorous adherence to statistical principles in analysis plan of endpoints

Comprehensive Study Management:

  • Study specific site suitability assessments
  • Site initiation and training capitalizing on technology and local resources
  • Remote document management and monitoring to achieve compliant Investigator Site Files
  • Rigorous follow-up on recruitment, intervention and adherence, and data cleaning
  • Risk-based monitoring utilizing a matrix of remote data (quality) monitoring, central statistical monitoring, site engagement strategies and on-site monitoring tailored to the study design
  • Efficient Site close-out due to comprehensive site engagement throughout study conduct

Data Management:

  • Medical review during database design and development of integrated case report forms
  • Real-time monitoring of data quality and feedback to sites and query resolution
  • Set up and management of Adjudication requirements including; development of Adjudication Committee, creation of validated outcome/ event definitions, training and QC of Adjudicators
  • Continual data review for unreported outcomes and QC of adjudicated outcomes/events
  • Coding and classification of data to international standards and dictionaries
  • Rapid execution of database close as a result of integrated site and data management

Regulatory and Contract and Management:

  • Support for regulatory applications and assistance for discussions/meetings with regulatory agencies
  • Management and maintenance of required regulatory documents from sites
  • Development, negotiation and management of site contracts internationally
  • Management of Investigator Fee payments based on performance and clean data criteria

Patient Safety and Ethics:

  • Creation of Informed Consent forms compliant with various national regulatory requirements
  • Safety reporting and reconciliation to sponsors or regulatory bodies
  • Provision of required documents to assist centres in submissions for ethics approval
  • Support for regulatory applications and assistance for discussions/meetings with regulatory agencies
  • Management and maintenance of required regulatory documents from sites
  • Development, negotiation and management of site contracts internationally
  • Management of Investigator Fee payments based on performance and clean data criteria

Publication and Clinical Study Report:

  • Statistical analysis for publication
  • Preparation of manuscripts
  • Presentation of results at key international conferences
  • Scientific expertise in review meetings with regulatory agencies

Study Infrastructure:

  • Creation of randomization and packaging lists
  • Proprietary central automated randomization platform integrated with clinical database and investigational product logistics
  • Management of specimen collection logistics (provision of kits, shipment tracking)
  • Research laboratory specializing in biomarkers for cardiac and diabetes and genetics analyses
  • Bio-bank facility for long-term storage of research specimens – all linked to study data
  • SOPs, Quality management and auditing for regulatory compliance