About Drug Safety
Drug Safety/Pharmacy vigelance is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
Our consultants perform safety monitoring and safety reporting practices in response to changing regulatory standards, allowing you to evaluate and manage risk over the lifetime of your product during early development safety and medical services and post-approval product support services.
Below are various kinds of drug safety services we offer to our clients
- Draft DSMB charters, operation planning and risk management.
- Protocol writing, compliance assessment, safety monitoring of clinical trials and maintenance of global safety data.
- Surveillance of SAE/AE initial documentation , processing, causality evaluations, literature-based drug class perspective evaluation, narrative composition of serious adverse events (SAEs)/Adverse Events (AE).
- Marketing services such as case intake/data entry, regulatory reporting, crisis management, dealing with litigation cases, literature Search and narrative writings.
- Data Collection (Lab data, imaging data, EKG and Qtc).
- Medical (MedDRA and WHO-DD) coding, medical quality review, literature review and safety review of the cases.
- MedWatch (FDA 3500A) and drafting of periodic safety update Reports (PSURs).
- Adverse event reporting and regulatory submission to US FDA, Canadian Health Authority and Indian Health Authority.
- Pre-registration signaling, signal Detection, post-marketing signaling and post-marketing signal assessments.
We excel in our industry so that you can get in yours
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Get in Touch
- Address:
Sathram Corp 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 - Email:
hr@sathramcorp.com - Phone:
732-380-5181 - Office Hours:
Monday - Friday : 9.00AM - 5.00PM