Starting from the general idea of a trial or implementation of pharmacovigilance processes, ZM Group is ready to take care of the work organization (Study Management Services), sites’ medical support (Medical Monitoring Services), necessary documentation generation and distribution (Medical Writing Services), as well as the overall safety insurance (Safety Management). All of our services are provided 24/7 by the most qualified specialists with diverse professional experience and strong academic background.
Qualified Specialists In
Medical and Clinical Affairs
Safety Management
Patient safety is the top concern in clinical trials. To protect your trial participants according to applicable international and local standards, we offer:
- Individual Case Safety Report (ICSR) Processing (Medical Evaluation of Cases)
- Safety Database
- Serious Adverse Event (SAE) Reconciliation (Necessary for Regulatory Authorities (RA) Submission)
- Serious Adverse Event (SAE) Narratives Preparation
- Case Report Form (CRF) and line-listings safety review (To address any site concerns regarding health state of participants)
Medical Writing
Our team is capable of preparing medical and regulatory documents necessary to run a Phase I-IV clinical trial, Post-Marketing Study, or perform drug safety activities in compliance with international and local standards.
- Study Abstracts
- Clinical Protocols
- Informed Consent Forms
- Patient Information Sheets
- Case Report Form
- Clinical Study Reports
- Risk Management Plan /Risk Evaluation and Mitigation Strategy (RMP/REMS)
Medical Monitoring
Medical Monitoring is the most effective way for a Sponsor to evaluate site effectiveness and guide them in achieving investigation objectives. With the experience in different phases of clinical trials and other types of human research (Phase I-IV, Post Marketing Surveillance, etc.) we are ready to:
- Provide Medical Monitoring Coverage 24/7
- Take up Data and Safety Management Board (DSMB) obligations
- Develop Safety Management Plan (SMP)
- Support Site and Study Team by providing specific medical consultations
- Provide Medical Insight on Study Documents Development
Study Management
With a great experience with trials in various therapeutic areas (Oncology, Cardiology/ Vascular Disease, Endocrinology, Psychiatry/Psychology, Immunology, Neurology, Pulmonology, etc.) ZM Group will help to perform:
- Project Management (from study planning to the final deliverable)
- Clinical Monitoring (patient safety, staff mentoring and data integrity monitoring)
- Site and Study Team Support (resolving any medical and trial conduct related matters)
- Essential Document Handling (for all document types)
- Site Management (collaboration with site members, clinical site preparation, procedures’ implementation)
