COVID-19 SECOND WAVE: WE CONTINUE TO STAY READY AND ACCOMMODATE REMOTE SOLUTIONS TO SUPPORT CLINICAL TRIALS

Amid the second wave of the COVID-19 infection across Europe and with lockdowns looming globally, ARENSIA continues to focus on keeping its staff and patients safe while remaining fully operational and ready to start new projects. 

We continue to strictly follow our Business Continuity Plan (BCP) with the same sanitation and protection measures for patients, staff and facilities. We also continue to ensure individual transportation for all patients from home, to our clinics, and back as implemented since the beginning of the COVID-19 outbreak.

As international travel is expected to encounter restrictions again (limiting Sponsor representatives visitation to our sites), ARENSIA is taking steps to ensure that this aspect does not restrain conduct of studies at its Research Clinics.   

We have put all necessary technical and human resources in place to offer both on-site and remote activities for:

• Site qualification visits
• Site initiation visits
• Monitoring
• Auditing

Remote Pre-study Qualification Visits and Audits: 

For the past 7 months, ARENSIA has and continues to host virtual visits, which are conducted with the same attention/presence as an in-person on-site visit. We have successfully passed a number of fully remote audits and qualification visits. As part of any remote qualification visit or audit, our responsible QA or Project Coordinator provides the requested documents upfront. Furthermore:

• We answer all questions directly via virtual communication lines (e.g. ZOOM) during audits/visits days
• We present/read documents via video without allowing recording and respecting all GDPR rules - this includes staff qualification records, verification of ICF, and unblinded medical history 
• We arrange individual virtual F2F interviews with principle investigator and selected team staff members

As part of any pre-study qualification process, ARENSIA offers virtual visits/ live transmission from our research clinics, which includes:

• Live circuit of facility, including complete tour with inspection of equipment, dedicated spaces and discussion of processes
• Sponsor can watch in real time presentation of wards, on-site laboratories, storage areas for frozen samples, medical and technical equipment, etc 

For example, the tour of on-site laboratories may include real time  check of the centrifuges, verification of equipment serial numbers and cross-check with respective documents from equipment list and maintenance documents. 

Remote Monitoring and Source Data Verification (SDV): 

We welcome local monitors at our Clinics, provided that the strict safety rules of our BCP are followed. 

For remote monitoring and source data verification we offer: 

• Shared pseudonymised copies of trial related source documents with the monitor;
• Verification of blinded source documents via email transmission, under the condition that they are destroyed after examination. Password encoded archives are used;
• Video review of medical records with clinical site team support, without sending any copies to the monitor, and without the monitor recording images during the review;
• Dosing supervision can potentially be performed if it is injection site shown in the video (with reliable protection of subject identity);
• Different other trial-related processes - like laboratory procedures, IMP preparation, etc. - can potentially be supervised remotely by the Sponsor in case that these processes are blinded. As examples of such tools, ARENSIA has experience with: 
  • Electronic verification of individual oral dosing (in collaboration with specialist AI vendor) 
  • Usage of sponsors electronic devices (e.g. tablets) for bed-side data entries

Please note: all video transfers shall be performed in compliance with Data Privacy Protection rules, including end-to-end security and pre-defined storage. 

We thank all our Sponsors and partners for the amazing support during these challenging times. 
We stay highly committed to each and every project!

16.10.2020