We know that nearly everyone around the world is dealing with some kind of impact from this pandemic. Our international teams have been meeting constantly over the past several weeks to devise plans and strategies to overcome the challenges presented to us by this situation. Some of the ways we can help you navigate these challenges include:
- Writing necessary protocol amendments due to changes or limitations in patient follow up and procedures
- Acting as a liaison with regulatory agencies to discuss next steps for trials delaying or ending enrollment
- Conducting Interim Analysis or developing Clinical Study Reports if a program is delayed due to a halt in enrollment
- Performing remote Pre-Study Visits, Feasibility and Monitoring Visits
- Collaborating with sponsors and vendors to have products shipped directly to research patients
- Guiding and supporting clinical research staff at sites and sponsors
- Assessing the economic impact of COVID-19 on clinical programs
If you are actively planning a program to address COVID-19
- Submit FDA/EMA/Regulatory submissions - expanded indications for products to treat or prevent COVID-19
- Use our extensive database of sites and patients to expedite study start up and enrollment for global expanded access programs and clinical programs
- Manage expanded access programs to utilize products to treat or prevent COVID-19
- Develop and manage any new US or global clinical trial for prevention or treatment of COVID-19
- Create Database/EMR analysis of specific regions with COVID-19
- Perform epidemiologic assessments of COVID-19-affected populations
Vaccine Experience and COVID-19 Site
CTI’s Clinical Research Center (CTI CRC) is a vaccine-experienced clinical research unit in Cincinnati, OH that has been conducting clinical trials for more than 20 years, and has completed over 900 trials across all phases of development. The team has contributed to multiple vaccine trials, including work in pandemic environments during the H1N1 (swine flu) outbreak, where the team conducted two Phase II trials and enrolled over 100 subjects in ~24 hours, and the H5N1 (bird flu) outbreak, where the Phase I trial went through an FDA audit with no 483s issued to the site. Additionally, the unit has collaborated with large pharmaceutical companies and emerging biopharmaceutical companies as part of trials resulting in vaccine approvals in areas including HPV, influenza, meningococcal group B, shingles and swine flu. The CRC has completed 15 recent vaccine trials with a 92% subject retention rate.
Our industry is in a unique position to substantially alter the future if we work together effectively. CTI is actively working on solutions to help our world as it fights COVID-19.
If you would like to help CTI care for the community
CTI is doing everything we can to help our communities during this pandemic. If you would like to join us, below are some ways you can help:
- Work with Gravity Diagnostics - CTI has been working with a local laboratory in Covington, KY, Gravity Diagnostics, to support their development of COVID-19 testing, from helping them source supplies to lending direct assistance from members of our staff. If you have any kind of lab experience and would like to help Gravity Diagnostics in the processing of tests and future development, please fill out this form and indicate your interest in working with Gravity Diagnostics.
- Donate to the NKY Coronavirus Emergency fund - CTI has already contributed to the fund to address the most pressing needs of the Northern Kentucky community during this unprecedented pandemic. We strongly encourage our partners in the Cincinnati/NKY area to do the same. If you are based elsewhere, we would ask you to check with your local resources to see how you can help in a similar way.
- Help feed students in need - CTI is supporting the Covington, KY school district provide food to the students who rely on school meals for their daily nourishment. You can support our local students as well by donating here. Or, if you are based outside of Cincinnati, reach out to your local school district to see what programs they have in place.
CTI cares for its people, and we encourage other organizations to do the same
We've never seen anything like COVID-19 before, but we've experienced recessions, policy changes, revolutions in technology, shortages in the workforce, and many other challenges over the past 20+ years. CTI has always prevailed because supporting our employees has always been a top priority. Below are some of the ways we are prioritizing our team members during this pandemic:
- Prioritizing safety - We instituted a global work-from-home policy and suspended all travel, whether a local government has required it or not.
- Offering flexibility - We have made sure our team knows we understand the family challenges they may be experiencing and have offered flexibility to their traditional work schedules.
- Ensuring stability and security - CTI has had zero layoffs in 20+ years. We immediately communicated to our employees that we do not intend to break with this policy. We are also guaranteeing full pay and offering financial assistance to employees in need.
We highly encourage our partners to adopt similar policies, and to put their people first. The world is relying on the pharma and biotech communities to develop the light at the end of the tunnel, and we cannot do so without the dedication and hard work of our amazing teams.
Stay well. Stay safe. Stay strong. We will get through this together.