We have read the news, reviewed the data, and heard it directly from our customers: The clinical trial industry has drastically changed with the emergence of COVID-19. For clinical research institutions, mitigating the negative impacts of COVID-19 on research activities has become a focal point. With research activities gradually resuming, research administrators and study teams may be faced with several challenges preventing them from conducting their trials and operations as effectively and efficiently as possible. Such challenges may include institutional hiring freezes, furloughs, restrictions on in-person activities, and changes in workflows and documentation.
Changes in staff availability and institutional resources can impact critical tasks such as data entry (impacting obligations made to sponsors for data provision) and data quality, and can burden remaining staff with additional protocol responsibilities. Advarra offers a number of services to help you restart research activities – such as Staff Augmentation. You likely have short-term projects to be completed quickly, or large ongoing projects delayed due to a lack of time and resources. We can assist with both.
The purpose of Staff Augmentation is to temporarily fill staffing needs. Our team is comprised of clinical research technology experts with experience at either OnCore® customer sites or on our product support team. We utilize our technology and clinical research experience and expertise to fulfill a number of roles on a customer team. These roles may include project manager, CTMS coordinator, business analyst, or trainer.
How can the Staff Augmentation team help you? With our knowledge of research, best practices, and software, we can hit the ground running to help tackle the problems customers are experiencing while restarting research activities. We have experience working remotely and continuing to push projects forward to meet goals. Even with restricted travel, we are still able to successfully provide support to our customers. Examples of how the Staff Augmentation team can collaborate with customers include:
- CTMS Coordination: Due to the pandemic, your research administrative activities may have changed, and you now require CTMS support. Our team can assist your institution with documenting workflows, developing standard operating procedures (SOPs), running queries, managing data, responding to end-user inquiries, tackling a support backlog, etc.
- Training: You may have revised your methods of delivering effective, comprehensive training due to working remotely. We can help your training staff create eLearnings and can plan and implement a shift to remote training. In addition, we can create/update training materials to current versions, including new features and workflows.
- Quality Control (QC) Management: With new restrictions, your site may now have time to develop a QC program, but you do not know where to start. Our team has experience in developing, validating, and analyzing QC reports as well as establishing a QC check system based on existing customer workflows.
- Report Analysis: With many studies placed on hold and new COVID trials rapidly evolving, you may face an increased demand for information and data from your leadership. Our team can analyze current reports and perform gap analysis on data reporting, working with your report writing staff to clarify questions, monitor progress, and create a quality assurance (QA) process for new reports.
- Operations Optimization: With research activities beginning to restart, now may be an appropriate time to perform an optimization of your current research state and desired goals. We can work with you to identify the tasks you need to accomplish to successfully achieve long-term goals, as well as provide next steps and considerations needed to ensure the project continues to progress.
- Project Management: As clinical sites begin to reopen to research activities, your institution may look to bring additional local sites (and end users) into your instance of the CTMS, but you may be lacking a project manager. Our team members can work with you to complete small-scale data migration, as well as train new users.
- Document Creation and Revision: With COVID-related changes to institutional guidelines and policies, you most likely need to create or update documentation to reflect these changes. We can review multiple documents and integrate them into training manuals, SOPs, and other materials. We can also restructure the documents to ensure they effectively communicate new requirements and standards to staff. Furthermore, we can provide a communication strategy (e.g. newsletters, tip sheets, etc.) for dissemination to study teams.
The clinical research industry is evolving to meet the changes brought about by the current environment. We continue to work closely with our customers to ensure they feel supported in the “new normal.” With the level of expertise our Staff Augmentation team brings to the research community, we have the knowledge and tools our customers need to successfully manage their research portfolios. As always, we are here to help you succeed. We stand with you to continue the great work of investigating and solving the needs of research and patients worldwide.
If your institution is struggling with restarting research slowed by COVID-19, we can help. Start the conversation today.