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Stem - Make The Future With Heart

Medical Strategy

Detailed

Most of the STEM’s medical department staff have global CRO background, with Medical Doctoral degrees, and with many years of clinical trial service experience. They provide medical strategy consultation services to clients with a global development vision, and with a balanced the risks and benefit of the project for clinical development; Leveraging external clinical expert resources, they design plans for clinical trials that in line with regulations and needs of clinical operations, with clear clinical trial direction, proposing an efficient and implementable medical strategies, for high-efficiency and cost effective, to support success of drug clinical development.

Medical Writing

Detailed

STEM's medical writing team has many years of clinical trial experience and has accumulated high-level medical writing capability for new drug programs, effectively support for drug clinical trials.

  • Medical Writing Services:

    Phase I-III and post-marketing reevaluation study clinical protocols;

    Investigator's manual, informed consent form and other clinical data;

    Research summary report;

    Writing the medical part of the registration declaration data;

    Literature search and review of clinical research;

    Translation of medical products and other medical articles.

Medical Monitoring

Detailed

STEM will carry out medical monitoring on the project according to the approved Medical Monitoring Plan (MMP). The staff of medical monitoring all have practical clinical experience. With stringent medical monitoring process to ensure the safety of subjects, improve trial’s quality and data’s integrity.

  • Medical Monitoring Services:

    To write a medical supervision plan;

    Training in programme and treatment areas;

    Answer the research team's inquiries on clinical protocols, etc., and assist in the establishment and maintenance of question and answer manuals;

    Provide full medical support to the clinical research team;

    The inclusion and exclusion criteria were checked to make sure that the subjects were eligible for inclusion;

    Review protocol violations and provide medical advice and solutions to reduce the occurrence of similar PD;

    Medical review of data on a regular basis.

PHARMACOVIGILANCE (PV)

Detailed

STEM's clinical trial service is carried out based on PV system throughout the whole process of drug clinical development, it has a complete standard process, meeting the requirements of regulations, integrating pre-marketing clinical research and post-marketing key projects’ monitoring. STEM is committed to building a drug safety information database with improved efficiency and cost effectiveness for our clients to ensure their drugs’ successful clinical development.

  • Pharmacovigilance Services:

    Formulation and implementation of safety management plans;

    PV system configuration;

    To deal with serious adverse events;

    Report of ICSR E2B;

    Reporting by ADR direct reporting system;

    Submission of AEFI report;

    Write and translate security update report (DSUR/PSUR);

    Key monitoring reports;

    Retrieval of adverse reactions in literature database;

    Drug safety alert consultation, training, etc.

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