In addition to recent pandemic outbreaks caused by viral infections, more treatment-resistant bacterial and fungal infections are increasing.
If your goal is to mitigate emerging threats and advance human health, you need thoughtful planning and conduct for successful clinical development. Veristat’s scientific-minded, infectious disease experts are devoted to helping you navigate this critical and challenging landscape. Our teams have conducted over 350 projects for Infectious Disease treatments and vaccines.
Developing an infectious disease therapy? Let’s Talk.
- +350 Infectious Disease Projects
- 18 Infectious Disease Marketing Applications Prepared
- 67% Of Prepared Marketing Applications Approved So Far
Experience Battling Infectious Diseases
Whether you are aiming to prevent or combat a viral, bacterial, fungal, or parasitic infection, Veristat can help make a difference for your study’s success. Our teams understand the nuances and difficulties involved with treating infectious diseases, have deep experience executing vaccine trials, and are adept with rapid response to global pandemics that arise, such as the recent COVID-19 response.
Veristat’s experts are poised to plan and launch your trials quickly providing:
- Development of regulatory strategy, expedited pathways, and regulatory agency interactions
- Clinical program planning, inclusive of statistical planning and analysis
- Agile patient recruitment strategies to support virtual trial and hybrid approaches
- Rapid deployment of clinical trial databases
- Virtual and remote clinical and medical site monitoring
- Data analysis and migration into CDISC formats
- Writing of clinical trial, safety, and regulatory documents
- Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.
- Ensuring post-market drug safety with Pharmacovigilance support
Case Study: Rapid Launch of a COVID-19 Vaccine Trial
At the onset of the COVID-19 pandemic response, a sponsor needed to quickly build their clinical trial database in order to start enrollment and randomization. Learn how we helped our client design and launch their trial plan in two weeks’ time, with patient randomization beginning the day of launch.
Recent Infectious Disease Vaccine Experience
- +70 COVID-19 Vaccines/Therapies
- +60 Influenza Vaccines
- +10 Respiratory Syncytial Virus (RSV) Vaccines
Knowledge From Broad Range of Infectious Agents
- Viral Infections
- Hepatitis (A,B &C)
- Human Papilloma Virus
- Respiratory Syncytial Virus (RSV)
- West Nile Virus
- Yellow Fever
- And more…
- Bacterial Infections
- Clostridium Difficile
- Intra-Abdonimal Infections
- Staphylococcus Aureus (including MRSA)
- Urinary Tract Infections
- Vacomycin-Resistant Enterococcal
- And more…
- Fungal/Parasite Infections
- Invasive Fungal Infections
- And more...
Develop a sound strategic plan for your infectious disease trial – speak to our experts.