Motivate
Lead by example
Mentor
Vision
WIN
Win
Teamwork
standards and quality assurance
innovative solutions
Good Clinical Practices (GCP)
International Commission on Harmonization (ICH)
Standards
Internal Standard Operating Procedures (SOPs)
Review records and procedures:
Interactions with Ethics Committees
Drug accountability
Site visits
Study documentation
Informed consent content
Inspect study-required facilities and equipment
Verify data collected in representative sample of
Case Report Forms (CRF-s) supported by source
documents
Ensure internal systems used in conducting clinical
trials correct:
SOPs for Adverse Experience (AE) reporting
Supplies distribution
Compare study report versus the protocol, CRF-s,
and database
Ensure internal report consistency
Preparation for sponsor and/or regulatory audit
Creative solutions include advice, structured programs, professional development and implementation across many areas including:
Accompanied Field Visits review
CRA/SCRAonsite performance
Clinical Development Plans
Clinical Trial Monitoring including site visits/co-monitoring
Ethics Application Process
Grant and Venture Capital Funding
Job Analysis, Skills Assessment, Competency
Profiling and Recruitment Planning
Professional Development and Staff Retention
Product Commercialisation
Regulatory Compliance
Staff Coaching and Mentoring
Strategic Planning
Training based on Competency Profiling and Needs Analysis
Quality Assurance and Investigator Site Audit
Analyze Your Business
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Business Plans
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Web Services
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Marketing Plans
Lean Manufacturing
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About Us
Our people are our secret to success. Approachable and highly experienced, our professional team has the
knowledge and experience to help your organisation reach new heights.
Principals, Susan Alder (MBBS, PhD) and Jane Campbell-Higgins (BSc, MPH) collectively have more than 50 years experience working in Pharmaceutical and Medical Technology Companies;
Government (Australia and Singapore); Clinical Laboratories; Hospitals; and Education. Both hold the Certificate IV in Training & Assessment and
have worked with organisations to assist change management, process improvement, systems development, and strategic planning.
Susan and Jane have science and medical backgrounds combined with experience in many therapeutic areas and all phases of clinical trials within a number of pharmaceutical, CRO and medical device companies. Together they have held every role involved in a clinical trial - from Investigator, CRA,
Project Manager, and Auditor, right through to Clinical Operations Manager, Medical Director and Regulator.
jane_minervamedica.com.au or call 0416 047 452
susan_minervamedica.com.au or call 0409 981 605
minerva medica will forward a detailed brochure outlining all services upon request
We look forward to meeting you!
minerva medica is a client focused organisation offering a range of consulting solutions, support and training in clinical research
