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 Compile, submit
and maintain Health Authority (MCC) clinical trial applications
(CTA)
Assist investigators
in preparation of Ethics submissions
Comply with Adverse
Event reporting obligations
Every CTA is compiled or overseen by a Project Manager and
critically reviewed by a second senior colleague prior to
submission. We currently have a 94% record of MCC approvals
on first review.
| Regional
Project Management |
Feasibility
assessments
Develop protocols, Case Report Forms and other key study documents
Identify and evaluate
clinical sites
Selection of national Principal Investigators
Organise investigator meetings
Manage investigator contracts and trial budgets
Manage Investigational Product importation, distribution and
destruction
Implement cold chain maintenance and special storage and transport
conditions
Prepare,
distribute and track key study documents
Co-ordinate central or local laboratory and other service providers
Maintain central
study files
Post-study document archiving and retrieval for audits
Prepare budgets
for study management/monitoring
Negotiate site, laboratory and other service provider budgets
and contracts
Administer site, laboratory and other service provider payments
nationally
Initiations and
closures
Data and safety
monitoring
Accountability
of investigational product
Maintain site
regulatory binders
CRAs experienced with Remote Data Entry and web-based CRFs
Follow Triclinium Standard Operating Procedures (or sponsor’s
SOPs)
| Clinical
Quality Assurance |
GCP and protocol-specific
training of site staff and monitors
Development of specific SOPs for local processes and regulatory
compliance
Clinical
site audits
For each study, our project managers insource as required the
following services from our virtual network of vendors and specialists:
Expert input
and review of clinical, epidemiology and pharmacoeconomic
protocols
Data Management
and Biostatistics
Qualified translations
of local language versions of consent forms, diary cards,
etc
Local printing
of Case Report Forms and study docs
Investigational
Product packaging and labelling in GMP facility
Customs clearance
of imported study materials
Refrigerated packaging
and transport
Accredited Central
Laboratory
Ancillary regional
laboratories where indicated
Courier services
Drug assays and
assay development in accredited analytical laboratory
Medical Writing
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