COVID-19 I Information Release 1
18, Mar 2020
Dear [Collaborator],
Sub:
RemediumOne’s preparedness towards efficient management of clinical trials across sites in Sri Lanka.
In our journey of 10 years in managing clinical trials in Sri Lanka we are facing global pandemic outbreak first time. This is a learning curve in our journey in managing complex clinical trials in resource limited and restrictions-imposed situation. We have taken this as an opportunity to enhance our tools and techniques in quality data generations and patient management.
We will ensure our best service to our collaborators like you in managing the clinical trials you are conducting in our country well. And will ensure that you receive the most accurate and updated information which will help you to plan new study requests, protocol specific activities and travel.
Currently Government has made several precautionary measures to control the outbreak.
• Holiday has been declared till 19th of March for public and private sectors. Essential services are not
functional as usual.
• Ports have been closed for two weeks.
• Curfew has been imposed in few identified high threat areas.
The above government implications were taken in consideration in making our plans. We would like to share the summary information on our preparedness through following tabulation. Please do not hesitate to contact any of RemediumOne staff in case of any assistance.
Kind Regards,
Samantha Ranatunga
MD/CEO
State precautionary measure towards controlling outbreak
• Information will be shared with you on weekly basis.
• Further disease prevalence information shall be obtained through Epidemiology Unit official website.
http://www.epid.gov.lk/
New study requests
Feasibilities
• No changes in current practices. In case of any delay the responsible person will inform promptly
Ongoing projects
Protocol specific activities
• All protocol specific activities will be performed without any delay.
E.g. Temperature monitoring
CRA travel arrangements
• Please liaise with our administration team or study lead to get updated information on travel advisories issued
by Sri Lankan authorities
Scheduled protocol visits
• Study coordinators are in constant touch with the patients in educating them the importance of schedule visits
• Will be decided in liaison with the study doctor for home visits to dispense IMP, drugs and perform schedule
medical assessments
• Temperature controlled IMP transfer has been arranged
• Arrangements for obtaining biological samples for laboratory assessments were made
Customs clearing of supplies
• We have had dialogs with all the relevant agencies to understand any delays. Any anticipated delays will be
communicated with you promptly.
• Closure of ports have been taken into consideration. Administration department is promptly gathering information
and make necessary arrangements.
• Curfew in some areas may delay transfer of goods. Precautionary arrangement in place.
Import licensing
• NMRA and University of Kelaniya are not closed their operations. Hence, we do not foresee any delays
Ongoing safety reporting and regulatory communications
• Respective ERC offices are functioning hence we do not foresee any anticipated delays in reporting
Staff commitment
• RemediumOne is committed to continue operations at research sites and head office with adequate safety measures.
• All staff were trained on managing Covid-19 situation.
• All staff were equipped with laptops and uninterrupted internet connectivity to carry day-to-day activities.
• Ensured constant supply of face masks and hand sanitizers
Remote monitoring support
• Staff were instructed and trained to support remote monitoring by CROs and Sponsors.
• Trained to share documents efficiently through electronic platforms and participate in web meetings and to
perform drug accountability remotely
Stakeholder commitment Medical officers and Allied health officers
• We are in constant engagement with the relevant parties and will ensure their commitment.
Regulatory authority and ERCs • Constantly in-touch with them to understand their work plan.
Clearing agents • In constant touch
Laboratory services • In constant touch
Archival and retrieval • In constant touch
Destruction services • In constant touch
Support services
Startup operations • No interruption in operations
Clinical Operations • No interruption in operations
Regulatory affairs • No interruption in operations
Finance – RemediumOne • No interruption in operations
IT support • No interruption in operations
Admin • No interruption in operations
HR • No interruption in operations
QA/QC • No interruption in operations
Facility management • No interruption in operations