Last month, the FDA approved tafasitamab-cxix (official name Monjuvi®) in combination with Lenalidomide as a...
Modality Solutions is the leader in clinical trial operations for vaccines for infectious diseases in emerging markets because we understand the challenges healthcare staff experience with proper storage and handling risks associated with temperature-controlled vaccines and biologics.
• Monitor vaccines and biologics depots and clinical trial logistics – on-site and in-country
• Supply cold chain logistics project management services
• Collaborate with NGOs, clinical trial operators, and local regulatory bodies
• Design thermal packaging improvements suitable for Zone 4 geographies
• Prepare for regulatory agency review
• Provide staff training and performance monitoring tools along with data query resolutions
• Improve product protection, anti-counterfeiting and tamper evidence measures
• Assist in evaluating incidents’ root cause, and provide tools for corrections
Modality Solutions is an expert in cold chain clinical trial logistics and offered operational and technical support to projects such as Ebola vaccination in Sierra Leone as well as operational and technical support for Centers for Disease Control and Prevention projects in the Democratic Republic of Congo. Assessed multiple sites for the National Institutes of Health (NIH) for its vaccine projects in the Caribbean. Just to mention a few.
Immunomedics (www.immunomedics.com) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment...
Covid-19 and the Race to Get a Vaccine Through FDA’s Supercharged Fast Track Approval Named Coronavirus Treatment Acceleration Program (CTAP)
The Coronavirus Treatment Acceleration Program launched by the FDA in response to Covid-19 is a...
Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets - these are some of...