ERG CLINICAL TRIALS IN THE TIME OF COVID-19

Letter from the CEO

Dear ERG Trusted Partner,

At ERG, we know that success in our clinical trials ecosystem, especially during an unprecedented time like that of the COVID-19 pandemic, means clear communications are not optional – they are indeed critical for effective planning for operational success. We are pleased to update you that all our portfolio and affiliate sites are open. Our ERG team stands ready to restart enrollment and to initiate new studies that have been postponed. Each site will continue to minimize risk and operate under their individual COVID-19 Risk Mitigation and Recovery Plans with each member of our team dedicated to ensuring the safety of study subjects, staff members, and everyone involved in the execution of our clinical trials. These plans are available by clicking here.

We would be remiss if we did not share that we empathize with all our colleagues, partners, and sponsors that are enduring the civil unrest across the U.S. In the interest of abundant precaution, we have increased security at our research locations, as necessary.

The increase in fear, anxiety, and depression during this most recent tragic chain of events has, on top of the emotional toll the COVID-19 situation has been taking on our country, makes it even more critical that we reopen our trials to patients suffering from mental illness and other debilitating disorders. Patients and family members are eager to re-engage in study participation with the hopes of advancing important medicines to market.

We are saddened to learn from recent (late May) industry reports that only 23% of sites are now open to enrollment of new participants. With several ongoing studies due to reopen for screening and many new trials preparing to initiate, we recognize our clients may have significant gaps in their execution plans and recruitment requirements. ERG is ready to support you, and your COVID-19 and non-COVID trials. If you have any immediate needs, I invite you to email TJ Calabrese at tcalabrese@ergclinical.com and we will schedule something within 24-48 hours.

While we continue to pivot to our new realities, we also seek to improve our appreciation and understanding of the core issues concerning each of our sponsors and partners. We look forward to receiving your insights and invite your feedback in our ERG survey. If you have not already received an invitation to complete our key client survey, please email your Account Director, TJ Calabrese, or me directly to participate.

Our ERG team remains committed to keeping everyone safe and healthy while conducting research studies. We continue to limit visitors to the site and will be prioritizing on-site monitoring visits and all visitors are required to provide the necessary information requested in advance and follow ERG’s guidelines while on-site. We will continue following all necessary federal, state, and local guidance and guidelines and update our policies and procedures via these communications updates and on our website.

Lastly, on behalf of our team at ERG, we continue to extend our gratitude to those of you, and your families, who are working bravely on the front lines of the COVID-19 pandemic who have put their lives in harm’s way to combat this virus. Our thoughts remain with those who have suffered the loss of a loved one or that has endured the fear of a negative outcome by receiving a positive test result.

Please stay safe and healthy, and feel free to contact me at lthievonwright@ergclinical.com anytime.

Regards,
Lori Wright

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Remote Monitoring

ERG has invested substantial time, training and financial resources to building a solid infrastructure that can easily pivot to working in a remote environment. All our ERG sites are now trained and currently utilizing our internal system for all Remote Monitoring Visits. Please download and review ERG’s Remote Monitoring Visit Policy.

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Remote Study Visits

ERG has prepared this guidance to facilitate ongoing trials with the use of virtual visits, where able, during the COVID-19 pandemic. Please download and review ERG’s Corporate Guidance: Remote Study Visits During COVID-19 Pandemic.

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Risk Mitigation & Response

ERG has been extremely proactive in its approach to the management of the COVID-19 pandemic and to ensuring the safety of study subjects, staff and others involved in the execution of its clinical trials across all sites. In order to mitigate current risks, we have amended our study processes and/or procedures at each portfolio site. Please download and review ERG’s site-specific COVID-19 Risk Mitigation and Recovery Plans by selecting the ERG Portfolio Site location from the map pictured below.

ERG Portfolio SitesERG Affiliate Sites


Woodland International Research Group

Little Rock, Arkansas

WIRG was one of the founding sites of Evolution Research Group, LLC and the established, long-standing team has over 80 years of combined research experience and over 200 years of combined clinical and psychiatric experience. WIRG has two inpatient units and conducts Phase 1-3 trials in adults, children, adolescents and elderly populations with an array of specialized procedures.


Woodland Research Northwest

Rogers, Arkansas

An inpatient and outpatient research clinic that conducts a mix of Early Phase (I/Ib) and Late Phase (II/III) trials. The site specializes in psychiatric and neurological research, but also conducts trials in sleep disorders, tobacco, addiction and in a variety of general medical indications.


Pacific Research Network (PRN)

San Diego and Rancho Bernardo, California

Two clinical research facilities in Southern California, where it has been a leader for over 35 years and provides quality research for both volunteers and the pharmaceutical industry. PRN has extensive experience conducting trials with new medications to treat Alzheimer’s disease, memory loss, anxiety, migraine, sleep disorders, sexual dysfunction, smoking, social anxiety, and weight loss.


Brain Matters Research

Delray Beach and Stuart, Florida

Our clinical research facility’s mission is to elevate Alzheimer’s disease research to the level of urgency that it deserves. BMR been conducting trials ranging from prevention, that seek to understand who gets this disease and why, to trials seeking to help current sufferers of mild, moderate and severe Alzheimer’s disease, or other dementias. BMR also conducts trials in other neurological disorders including essential tremors, migraine and movement disorders, among others.


Neuropsychiatric Research Center of SWFL

Fort Myers, Florida

The Neuropsychiatric Research Center in Southwest Florida has conducted over 100 clinical trials in Alzheimer’s disease (AD) and is dedicated in finding effective treatments for those with mild cognitive impairment (MCI) and mild to moderate and severe AD. FLCR also conducts trials for other neurological disorders including ALS, essential tremors and other movement disorders, as well as select sleep disorder and psychiatry studies.


Clinical Pharmacology of Miami (CPMI)

Miami, Florida

Founded to serve a real need with its high-quality, state-of-the-art 120-bed clinical pharmacology research unit, CMPI has the experience and facility to conduct safe, precise, well controlled clinical research with new and existing drugs to meet the individual needs of each sponsor and research protocol.


Finger Lakes Clinical Research (FLCR)

Rochester, NY

Conducts adult, child and adolescent clinical studies with a focus on central nervous system (CNS) trials. These clinical trials encompass a broad range of illnesses including anxiety disorders, ADHD, major depression, post-traumatic stress disorder (PTSD), bipolar (manic/depressive) illness and schizophrenia. In addition, FLCR has experience in peripheral neuropathy (pain) studies and cancer pain trials and has expanded into rheumatology and immunology by adding an additional highly experienced Principal Investigator.


Richmond Behavioral Associates (RBA)

Staten Island, NY

RBA is an established outpatient research center in a densely populated borough of NYC.  Their experience and expertise cover the full range of Phase II, III and post marketing studies for all CNS indications including depression, anxiety, bipolar disorder, schizophrenia, Alzheimer’s disease, sleep disorders, obesity, diabetic neuropathic pain, chronic low back pain, among others.


Midwest Clinical Research Center (MCRC)

Dayton, Ohio

As the only site in Dayton, Ohio dedicated to conducting CNS clinical trials, MCRC is dedicated to working with sponsors and volunteer subjects to test and develop new medication therapies for psychiatric conditions, neurological disorders, sleep disorders, acute pain (post-surgical) and chronic pain, vaccines, eating disorders, addiction and tobacco product trials, among others.  In addition to its outpatient clinic, MCRC has an inpatient 21-bed clinical research unit where we have conducted phase 1-3 trials for multiple sponsors in various specialized populations.


Endeavor Clinical Trials and Endeavor In-Patient Surgical Unit

San Antonio, Texas

Endeavor Clinical Trials has over 20 years of experience conducting research and clinical trials specializing in post-op pain, diabetic-related pain, other pain, diabetes, vaccines, dermatology and podiatry. ECT’s new, state-of-the-art, purpose-built clinical research unit includes 18 private rooms and two surgical suites.

Frequently Asked Questions (FAQ)

Everyone from ERG is working together to maintain the safety, security, and health of all our study subjects, staff and others involved in the execution of its clinical trials, across all our sites. We are working diligently to keep everyone abreast of the latest information available about our policies and procedures through multiple channels.  Please review the answers below to some of our ERG COVID-19 Frequently Asked Questions.

For the latest frequently asked questions about COVID-19 please visit the Centers for Disease Control and Prevention (CDC) with content from the National Center for Immunization and Respiratory Diseases (NCIRD) – https://www.cdc.gov/coronavirus/2019-ncov/faq.html

Activation of plan

ERG has been extremely proactive in its approach to the management of the COVID-19 pandemic to ensure the safety of study subjects, staff and others involved in the execution of its clinical trials across all sites. The ERG team has assembled to advance its pandemic planning process to determine how to mitigate current risks by amending study processes and/or procedures. ERG’s site-specific COVID-19 Risk Mitigation and Recovery Plans are now finalized and available for download on the ERG website.

The final authority for decision-making falls to ERG’s Crisis Management Team (E-CMT) the membership of which includes the CEO, CMO, COO, CFO, CIO and VP of Quality Assurance and Compliance and Director of Human Resources.  Each site’s leadership team, including the Site Director and Principal Investigator as well as the Executive Directors of Clinical Operations work together to develop plans and solutions which are then presented by the Chief Medical Officer and the Chief Operating Officer at the daily E-CMT meeting.

While all sites are providing services and conducting patient visits, some of ERG’s sites are operating in areas where the E-CMT and the Site Leadership determined that moving to a largely remote operational model was prudent.  These include Brain Matters Research and Clinical Pharmacology of Miami in Florida, Richmond Behavioral Associates in Staten Island New York.  However, all sites are conducting limited on-site visits with a skeleton staff, in addition to remote patient visits.  We expect these sites to begin to move towards more of an “on-site” operational model in the coming weeks.

The other ERG sites are open and conducting both inpatient and outpatient trials under their individual COVID-19 Risk Mitigation and Recovery plans.  ERG expects that all sites may continue to operate under a hybrid model of both on-site and remote visits going forward and are fully prepared to continue to do so.

Communications transparency

ERG remains in constant direct contact with our study sponsors and CROs, working together to find alternative approaches to maintain trial participant safety and trial data quality and integrity.  In fact, ERG’s team obtained input from sponsor and CRO partners before finalizing its COVID-19 Risk Mitigation and Recovery Plans.  Our approach has been more one-on-one communication with our clients rather than communicating all actions through social media.

COVID-19 research focus and proficiency

ERG has formed a dedicated team that meets weekly to review potential opportunities to be engaged in COVID-19 research. We are prioritizing our focus on COVID-19 vaccine trials. We are also reviewing each treatment study on a case-by-case basis and weighing the possibility if we think that each could be done with minimal risk of exposure to our staff.

Recovery phase post-COVID-19

ERG has observed that the industry has been heading toward more of a virtual environment for many years. ERG does not believe that we will be returning to former processes. The COVID-19 pandemic is simply forcing those who did not believe that these changes were imminent to pivot quickly. ERG’s senior leadership team, board of directors and clinical teams are confident, nimble and adaptive. The ERG mindset is less focused on “why” we may need to change course. The entire team is thoughtful and focused on “how” effective and efficient we make accommodations and streamline our processes.

The current unprecedented situation has required ERG to be true contemplatives in action as we envision our roles beyond the immediate challenges. This approach ensures that all actions taken by our leadership and team are well thought out and further enhance the stability of the overall organization.  ERG simply cannot think “short-term” when faced with something of this magnitude, and when the virus is ultimately eliminated, the memory of this historic time will endure in our minds and our daily engagement.

Exposure to COVID-19 and quarantine plan

ERG’s chief operating officer and chief medical officer have established procedural steps to first ensure direct communications with the specific site director and one of the site investigators. Following direct phone communication, the team determines the plan of action for the site and the individual. Each plan is highly individualized and variable, considering the site location, degree of exposure, site mitigation plan as well as ensuring compliance with Centers for Disease Control and Prevention (CDC) guidelines.

Staffing

ERG is pleased that we have been able to maintain our highly trained, dedicated staff at all our site locations aligned to the current needs of our sponsors/CROs. Unfortunately, due to a large percentage of our trials being placed on hold, and the corresponding reduction in operating capital, ERG has asked employees to voluntarily take furloughs. The furloughs will affect both management and nonmanagement positions. Affected employees will retain health benefits and can apply for unemployment. Furloughs will be reevaluated weekly and we expect most if not all of our staff to return to work by mid-May.

As part of our dynamic cross-functional mobilization, some members of the ERG staff continue to work remotely with reduced workloads and have been reassigned to some exciting projects in other departments (i.e., finance, business development and marketing, market research) that they otherwise would not have had the opportunity to explore.

Technology infrastructure

Since its founding in 2014, ERG has invested substantial time, training and financial resources to building a solid infrastructure that can pivot to working in a remote environment. Recent weather and other notable events in our country have illustrated the need for ERG to be actively involved in crisis and issues preparedness to protect each of our sites and preserve the integrity of our trials. ERG planning has been an ongoing process that requires detailed preparation before unforeseen events, seamless execution during a time like this current pandemic and active engagement in planning during the recovery phase. ERG is recognizing the benefits of our investments in remote visits and monitoring and is now simply accelerating the mobilization of our own best practices.

ERG has always had mobility in mind and all our implemented technologies were deployed with that philosophy. Our staff has the same access to all our applications, Clinical Trial Management System (CTMS) and productivity suite from home just as they would in their respective offices.

ERG utilizes our Microsoft Teams platform to provide virtual visit capabilities to our patients.
We collect eConsent documents via DocuSign. Microsoft Teams uses industry standard encryption and can provide audio/video and messaging functionality. Built on the secure and compliant Microsoft 365 cloud, Microsoft Teams enables HIPAA compliance and is compliant with standards like HITRUST, SOC 1, SOC 2, GDPR and more. For more information about how regulatory compliance is achieved, please review the following information presented by Microsoft – https://www.microsoft.com/en-us/microsoft-365/blog/2019/04/30/white-paper-microsoft-teams-healthcare-providers-hipaa-compliance/

ERG uses Microsoft 365 to provide Microsoft Teams and Microsoft SharePoint functionality. Data are encrypted at rest and in transit, using several strong encryption protocols, and technologies that include Transport Layer Security/Secure Sockets Layer (TLS/SSL), Internet Protocol Security (IPSec), and Advanced Encryption Standard (AES). For more information on encryption in Microsoft 365, please review the following information presented by Microsoft – https://docs.microsoft.com/en-us/microsoft-365/compliance/encryption?view=o365-worldwide