Open for Business: Early Phase Clinical Drug Development during the COVID-19 Pandemic
The global COVID-19 pandemic has altered the mechanics of nearly every industry. For early phase clinical trials, adapting to this crisis has led to augmented risk mitigation procedures and greater use of innovative technology. Since continuity of your drug program is important to you, the patients in need of these therapies, it is important to us.
We have taken a proactive approach to conducting business, now when research is needed more than ever. Our strengths lie in being flexible and nimble, which is a benefit during times of uncertainty.
Our ‘New Normal’ is built on three key pillars; Safety, Resources and Communication.
The health and safety of our participant and staff is of the utmost importance. We have incorporated several measures to screen, clean and isolate for COVID-19 virus during trial operations. We are following all CDC, FDA and MHRA guidelines as well as local regulations for clinical operations during the COVID-19 pandemic.
- Health Checks: All participants, staff and visitors will have their temperature checked and queried about COVID-19 symptoms or contact with positive patients upon entering Celerion facilities. Access will be denied to anyone showing symptoms of the disease.
- PPE: All participants, visitors and staff will wear appropriate PPE while at the Clinic.
- COVID-19 Testing: Regular PCR screening for virus detection and antibody testing for potential immunity will be performed.
- Cleaning: Amplified cleaning measures have been put in place with special attention being paid to high-touch areas. Regular hand washing is encouraged for all participants and staff, and hand sanitizer is available at facility entry points and throughout the building.
- Social Distancing: Isolation and distancing procedures are now in place. Participants will E-consent prior to screening and experience staggered screening as well as segregation in the clinic. Staff are instructed to work within their zoned areas, maintain 6 ft. social distance as much as possible, limit face-to-face interactions and time spent in common areas.
Testing, Testing, Testing! Celerion Bioanalytical Services has focused capabilities on COVID-19 screening by PCR, viral load quantification, antigen detection, antibody titer measurement, cell-mediated immunity assessments as well as cytokine and chemokine inflammation biomarker assays.
We Lead Quality
We have the essential resources in place to safely and effectively execute your clinical trial.
- Supply Chain: We have secured the necessary PPE for our staff and participants.
- Celerion Express: New screening facility located at the Nebraska Innovation Campus.
- Bed Capacity and Space: 3 Clinical Pharmacology Units – 600 bed capacity
- Enough beds to accommodate social distancing during participant confinement
- Lincoln, NE = 200 beds & 50,000 sq. ft.
- Phoenix, AZ = 300 beds & 105,000 sq. ft.
- Belfast, UK = 100 beds & 29,000 sq. ft.
- Pharmacy Capabilities: Specialized Bio-Safety Level 2 (BSL-2) USP Compliant
- Recruitment: Robust database of +130 000 participants
- Experienced Workforce: +1000 Employees
- Thoroughly trained Clinical Associates
- Medical and Subject Matter Experts
- Clinical Pharmacology team with expertise in study design, data analysis, interpretation and medical writing
- Knowledgeable Bioanalytical Scientists
Communication is Key
With conditions rapidly changing, effective communication among all stakeholders is critical.
- Response Plan: A Celerion Pandemic Management Plan is distributed to our clients prior to study start. This report outlines risk mitigation steps, training procedures and screening activities.
- Adapting to Regulatory Guidance: We are in regular communication with IRB and IEC, and we are quickly disseminating and incorporating FDA, EMA, MHRA guidance regarding the COVID-19 pandemic.
- Leveraging technology: We engage innovative tools to support virtual meetings and remote data review. Our clients are provided with real time data accesses through our Celexus® system.
- Celexus® is Celerion’s client data portal. It is an information hub with real-time access to safety data and trial progress dashboard.
During this dynamic situation, the steps we have put in place for the safety of participants and staff, securing supply chain and innovative technology are designed with one objective in mind, to help our biotech and pharma partners get their products to market faster.