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Infectious diseases and other emerging health challenges are a threat everywhere—not just in low-income and non-Western countries. The United States and the entire world must be equipped with the means and treatments to quickly address and mitigate emerging threats, both small and large.
As an Infectious Disease and Vaccine CRO, we have worked on studies for:
Pharm-Olam is investing in strategic relationships across the globe to build out a network of partners and vendors to support our sponsor's unique requirements for infectious disease and vaccine research, including:
Pharm-Olam has a long and successful history in the anti-infective area of drug development. As a anti-infective experienced CRO, we have supported the development of more than 50% of all antibiotics approved by FDA/EMA since 2010. We have supported multiple marketing approvals by completing pivotal studies for the following indications:
Infectious Disease and Vaccine research requires exceptionally well thought-through protocol development. One incorrect endpoint can mean the difference between successfully meeting milestones, or costly delays and out-of-control budgets.
Pharm-Olam's Infectious Disease and Vaccine division, led by Dr. Slobodan Ilic, can assist in this development, ensuring that across all functional areas the strictest adherence to protocol and regulatory requirements are established and maintained. In addition, our Chief Medical Officer, Dr. Kelly McKee has spent the better part of his 40+ year career in infectious disease research, and is available to sponsors for oversight and consultation.
With Infectious Disease and Vaccine clinical research constantly changing, there is much debate and inconsistency across countries as to what constitutes a study endpoint. Pharm-Olam is adept and experienced at knowing and anticipating these requirements, and formulating a complete risk management plan, based on our Bow Tie Method to mitigate risk (in study timelines, budgets, recruitment, document filing, etc.).
Our Bow Tie, risk-based methodology analyzes potential and actual risk scenarios, anticipating and mitigating risks appropriately and proactively. Real-time trend analysis on every level is possible to meet oversight obligations.
Arguably the biggest challenge in ID/Vaccine research, finding the right patients in the volumes or with the disease state required to meet testing needs.
From recruiting healthy volunteers to in-patient population study designs, Pharm-Olam's global partnership network, including in countries throughout Africa and South America, means rapid start-up and activation timelines.
We understand and can respond to the seasonality demands of various infectious diseases, and we ensure on-the-ground support for community outreach and patient engagement. Our 700+ staff members are located in strategic countries, and provide sponsors and clinical research teams alike guidance and insights into what opportunities present the best chance of success.
These factors, and many more, make Pharm-Olam a great choice for sponsors of all sizes, who need a nimble, connected team with vaccine clinical trial knowledge and infectious disease expertise.
Infectious Disease and Vaccine research often touches the youngest among us with a veracity unseen in other indications. Sponsors are racing to discover breakthroughs that will eradicate the vicious diseases that affect so many.
Pediatric trials, though, often face a complex set of criteria and considerations, including informed consent, study endpoint definition, patient recruitment and access to patients that fit the desired disease-state criteria.
Pharm-Olam’s pediatric specialty services are born of over two decades of progressive, complex research study experience, and our physicians and regulatory experts are able to provide advice specific for the conduct of studies in this unique and vulnerable population.
US government funding currently supports more than 100 global health products in clinical trials, including a robust pipeline of cutting-edge technologies poised to deliver dramatic improvements in the diagnosis, treatment, and prevention of diseases including HIV/AIDS, Ebola, Zika, and others.
Our US Government Federal Research Services group consists of tenured experts, who help ensure that studies are set-up to provide evidence-based results with reduced risks, controlled clinical program costs and a shortened time-to-market. Strict adherence to protocol means we keep the promises we make, leading to lasting relationships with our government clients.
Whether it is an antibiotic, antiviral, antimicrobial, or vaccine, Pharm-Olam is ready and experienced at moving all types of clinical research through regulatory requirements and required processes across all types of patient populations, including emerging clinical research markets like Africa, and Latin and Central America.
DID YOU KNOW? Pharm-Olam staff have worked on infectious disease studies or acted as the vaccines CRO for BARDA, the NIH, the Bill & Melinda Gates Foundation, and more.