At Aptuit, safety of subjects participating in clinical research is paramount.
Aptuit offers a comprehensive package of clinical safety services covering different
stages of development from entry into man to end of phase II. At Aptuit, the clinical
safety services are provided by a team of experienced pharmaceutical physicians
who work closely with an integrated and global team of preclinical and clinical
researchers. Clinical safety services are performed with high standards, following
Aptuit’s written Standard Operating Procedures and complying with Good Clinical
Practice (GCP) and local regulations
Our clinical safety services include:
Medical Monitoring
At Aptuit, the medical monitor works closely with the Sponsor and each internal
integrated project team throughout the course of a study and/or a clinical development
plan.
Medical Monitoring Services include:
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Advice to Global Product Development Strategies
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Sponsor Representation with Regulatory Agencies (when required)
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Contribution to the definition of study design, and the development of study protocol, informed consent, investigator’s brochure and other study-related documents
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Investigator/Site Training on study safety procedures
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Support to site personnel 24/7 on medical matters including answering eligibility questions from investigator and ongoing review of safety/efficacy data
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Evaluation of Serious Adverse Events, including regulatory aspects
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Medical Review of Statistical Analysis Plans
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Medical Review of Clinical Trial Reports
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Literature Evaluation (Disease Background, Competitor Analysis)
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Clinical safety assessment of due diligence packages
Pharmacovigilance (pre-marketing)
Aptuit offers a comprehensive global pharmacovigilance service for a clinical study
and/or a clinical development plan up to end of phase II. Aptuit provides full support
to meet client’s international obligations for adverse event reporting.
Pharmacovigilance Services include:
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Safety Management Planning
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Intake and Processing of Serious Adverse Event reports
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Medical review and causality assessment of Serious Adverse Event reports
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Global Regulatory Reporting (Paper or Electronic submissions)
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Safety Reporting to Investigators/IRBs
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Periodic Safety Update Reports (PSURs), Annual Reports or End of Study Reports
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Coding Review using Regulatory Dictionary Coding - MedDRA, or Sponsor Specific
Integrated preclinical and clinical safety assessment
At Aptuit, the pharmaceutical physicians work with an integrated team of toxicologists,
pharmacologists, drug metabolism and CPK/MS experts to provide a strategy individualized
for every compound and focused on risk mitigation to ensure FIM studies are conducted
safely.
Integrated preclinical and clinical safety assessment services include:
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Review of preclinical safety packages
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Definition of safety margins
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Interpretation of preclinical findings and its relevance to man
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Establish the preclinical safety risk assessment plan
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Selection of safe starting dose for FIM study
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Definition of clinical safety monitoring plan and stopping criteria for implementation in FIM study
Set-up and management of IDMC
If required as part of a clinical development plan, Aptuit has the expertise to
establish and manage an Independent Data Monitoring Committee (IDMC) (also referred
to as Data Safety Monitoring Boards).
IDMC Services:
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Identification and Recruitment of Members
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Charter Development
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Data Analysis and Preparation of IDMC Reports
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Meeting Coordination/Facilitation
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Record Meeting Minutes
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Provide IDMC Recommendations to Sponsors