Safety and Pharmacovigilance | Comac Medical

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Solutions

Early Phase Clinical Trials

Performing Clinical Part of Early Phase Projects

Phase I Clinical Research Unit

Study Drug Management

Non-Interventional Studies

Clinical and Bioanalytical Laboratories

Site Start-Up and Clinical Trial Monitoring

Medical Monitoring

Project Management

International Research Network

Site Management and Patient Recruitment

Regulatory Affairs

Medical Writing

Clinical Data Management

Clinical Biostatistics

Safety and Pharmacovigilance

Clinical Site Supply

Clinical Trial Planning and Design

PK/PD Modelling

Safety and Pharmacovigilance

Short overview of the services our team offers in drug safety management is shown below:

Clinical trials safety management
- Preparation of SMA
- Full processing of individual cases
- Periodic reports preparation (line listings, DSUR)
Post marketing activities
- Literature search and review
- Product complaint managements
- PSMF Preparation and Maintenance
- Risk-Management, crisis management & consulting (preparation of RMP)
- Qualified Person for Pharmacovigilance (QPPV) in Europe
- Local (PV) contact person
- Aggregate periodic reporting (PSUR, etc.)
Safety Database hosting with electronic regulatory reporting in EudraVigilance
Global interaction with and reporting to Competent Authorities
Generation of CIOMS Reports
Product Reporting within XEVMPD

Therapeutic Areas

We have experience in the following therapeutic areas:

Cardiology

We have experience in the following therapeutic areas:

Cardiology

We have experience in the following therapeutic areas:

Gastroenterology

We have experience in the following therapeutic areas:

Gastroenterology

We have experience in the following therapeutic areas:

Dermatology And Venereology

We have experience in the following therapeutic areas:

Dermatology And Venereology

We have experience in the following therapeutic areas:

Medical Devices

We have experience in the following therapeutic areas:

Medical Devices

We have experience in the following therapeutic areas:

Endocrinology

We have experience in the following therapeutic areas:

Endocrinology

We have experience in the following therapeutic areas:

Hematology

We have experience in the following therapeutic areas:

Hematology

We have experience in the following therapeutic areas:

Immunology

We have experience in the following therapeutic areas:

Immunology

We have experience in the following therapeutic areas:

Infectious Diseases

We have experience in the following therapeutic areas:

Infectious Diseases

We have experience in the following therapeutic areas:

Metabolic Diseases

We have experience in the following therapeutic areas:

Metabolic Diseases

We have experience in the following therapeutic areas:

Nephrology

We have experience in the following therapeutic areas:

Nephrology

We have experience in the following therapeutic areas:

Neurology

We have experience in the following therapeutic areas:

Neurology

We have experience in the following therapeutic areas:

Obstetrics And Gynecology

We have experience in the following therapeutic areas:

Obstetrics And Gynecology

We have experience in the following therapeutic areas:

Oncology

We have experience in the following therapeutic areas:

Oncology

We have experience in the following therapeutic areas:

Lymphomas

We have experience in the following therapeutic areas:

Lymphomas

We have experience in the following therapeutic areas:

Ophthalmology

We have experience in the following therapeutic areas:

Ophthalmology

We have experience in the following therapeutic areas:

Pain Management

We have experience in the following therapeutic areas:

Pain Management

We have experience in the following therapeutic areas:

Pediatrics

We have experience in the following therapeutic areas:

Pediatrics

We have experience in the following therapeutic areas:

Psychiatry

We have experience in the following therapeutic areas:

Psychiatry

We have experience in the following therapeutic areas:

Rare Diseases

We have experience in the following therapeutic areas:

Rare Diseases

We have experience in the following therapeutic areas:

Respiratory Diseases

We have experience in the following therapeutic areas:

Respiratory Diseases

We have experience in the following therapeutic areas:

Women’s Health

We have experience in the following therapeutic areas:

Women’s Health

We have experience in the following therapeutic areas:

Non-interventional Studies

We have experience in the following therapeutic areas:

Non-interventional Studies