CerbACT Asia Opening Ceremony

On September 30, 2021, Cerba Research and ACT Genomics held the official opening of their joint venture CerbACT Asia. The immuno-oncology center of excellence located in Taipei, Taiwan, combines the strengths of the central lab and specialty lab to offer a comprehensive service for research within the immuno-oncology space. We would like to thank everyone who was present at the ceremony, whether virtual or in person, to celebrate this new venture. Below, please find a short recap of the ceremony.

 

Learn more about CerbACT Asia, and how we can support Immuno-Oncology clinical research through PBMC/Cell Isolation, Flow Cytometry (FCM), and Immunohistochemistry (IHC) here: CerbACT Asia – Immuno-Oncology Center of Excellence.

About Cerba Research: Is a leading healthcare company with end-to-end drug development and diagnostic solutions to optimize R&D drug productivity and commercialization. Providing Early phase research, clinical development through central laboratory and diagnostic services, Assay and biomarker development and validation. Working with government agencies, non-government organisations as well as pharma and biotech organisations to change the shape of clinical development.
Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.

For more information: www.cerbaresearch.com

About ACT Genomics: Is an innovation-driven cancer solution provider in Asia with offices in Taipei, Hong Kong, Singapore & Tokyo. With our Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team and proprietary AI algorithms, we provide optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Together, we “Turn Genomics into Action.”

For more information: www.actgenomics.com

Expansion of US Facility: Increased Capacity & Testing Capabilities

We reached an essential milestone in our company history in July, completing our US expansion. Leaning on our values of courage, innovation, and commitment, our increased capacity and expanded service offer enables us to continue growing our operational and scientific teams to support client needs.

The move and expansion were a success, with no disruption to ongoing studies and continuity of service to our clients, thanks to the dedication of our employees.

Improved capacity and service offer:

  • Additional 15,000 sqft of space – increased to 35,000 sqft
  • State of the art in-house Flow Cytometry Laboratory increases its capacity
  • Increased PBMC and cell isolation capacity
  • Expanded in-house Immunohistochemistry (IHC) solutions for biomarker discovery through to clinical validation
  • Increases sample handling and logistics areas for central lab services
  • Growth of our scientific and operational teams to support client needs

New address: 10 Nevada Drive, Lake Success, NY 11042

Brexit Communication

Due to the upcoming Brexit changes for international trade with the UK, we are writing to provide an update on how Cerba Research is preparing for this change and how the changes may impact your clinical site. Please be assured that we are closely monitoring the Brexit requirements, and we are implementing actions to minimize any disruptions to our services. The summary below provides key information on the changes taking place.

Airwaybills and Pro Forma Invoices

Since the UK will no longer be considered part of the EU, it will have requirements similar to other non- EU countries. This includes the completion of key paperwork such as pro forma invoices and updated airway bills.

  • For shipment of samples (ambient or refrigerated) to Cerba Research currently performed with a standard courier (DHL or TNT), we will be sending your clinical site Pro Forma invoices and non-EU airwaybills.
  • For shipment of samples provided by premium couriers, the courier will provide Pro forma invoices and non-EU airwaybills at the time of pick up.
  • For Frozen shipments, Pro forma invoices and non-EU airwaybills will be provided by the courier when they deliver dry ice at your site.

Economic Operator Registration and Identification Number (EORI)

In the event the UK exits the EU with no deal and a customs border is enforced, an EORI number will be required post Brexit (starting from 1 Jan 2021). To mitigate risk, we are recommending that any sponsor trading between the UK and EU register for an EORI number.

  • The EORI number must be entered on the Proforma Invoice to promote smooth and fast customs processing and clearance.
  • From 1st January 2021, the UK will be considered as a non-EU country and all requirements needed for shipment from non-EU countries will also apply to the UK.
  • The EORI number must be obtained by the clinical trial Sponsor.
  • For more information on obtaining an EORI number please visit https://www.gov.uk/eori

Avoiding Transit Time Risks

Although Couriers have expanded their network and customs clearance capacity, we are recommending planning an additional 2 working days for delivery of supplies from Cerba Research, required during the first weeks of January.

If you have any additional concerns and/or questions, please do not hesitate to contact Cerba Research at [email protected]

Cerba Research and all our dedicated couriers will do their utmost to assist you in any enquiry.

End of Year Communication and Global Closing Days

As we approach the end of year 2020 holiday season, Cerba Research would like to provide you information related to our operational and courier services. 

COVID-19 – Impact on Courier services

  • Recent increases in COVID-19 cases and associated country lockdown restrictions globally have impacted commercial travel and limited the flexibility of premium couriers. Due to this, we would recommend using standard carriers that have their own fleets for transportation and are not reliant on commercial airlines. This includes FedEx, DHL, TNT and UPS/Marken. This does not apply to Africa, where we would recommend the use of Biocair and World Courier.
  • There is an increase in transit times particularly in the courier transportation lane between US and Europe and between Europe and US. This may have an impact on any samples with less than 48 hours stability.
  • Cerba Research is closely monitoring all shipments with our courier network to ensure shipments can be collected and delivered on time where possible.
  • Cerba Research is also working towards ensuring we can support alternative solutions where possible and feasible.

COVID-19 – Impact on Procurement of lab kit supplies:

  • Due to overwhelming global demand for specific lab supplies related to COVID-19 testing and investigation, we are experiencing extended lead times for some supply items.
  • The supply constraints are being monitored and managed closely by our Global Procurement team and we have been able to minimize shortages.
  • Despite best efforts, it is possible that we may experience short term supply disruptions that ultimately impact delivery lead time of our supply kits.
  • We would recommend allowing an additional two weeks for any kit orders placed and we would request that you place any resupply requests to Cerba Research as soon as possible if you require delivery before 20th This does not apply to Barc South Africa, where we will continue to provide the supply of kits within normal timelines.

Cerba Research Closure Days

Our labs are closed on the days noted below, please take your shipment transit time into consideration to ensure the sample(s) arrive the day before a Closure Day.

Cerba Research Europe & USA: Closed 25-December (Christmas Day) and 1-January (New Year’s Day)

Cerba Research South Africa: Closed 16-December and 25-December (Christmas Day) and 26-December and 1-January (New Year’s Day). Please note Barc South Africa will be open for reduced hours on the public holidays.

Cerba Research Australia: Closed 25-December (Christmas Day), 28-December and 1-January (New Year’s Day)

SRL Japan: Closed 25-December (Christmas Day), 29-December through to 03-January 2021 (New Year’s Holiday)

Local Public Holidays

  • Please do not ship samples on the day(s) before local public holidays or on local public holidays. If agreed otherwise for your trial, please confirm arrangements in advance with your courier.
  • For Barc South Africa: Please notify the Barc South Africa team before sending any samples to ensure the shipment can be tracked as there can be delays in customs within Africa during the holiday period.
  • For Russia and Ukraine: Please try to avoid scheduling patients from December 20th till January 10th as these countries have an extended holiday period. If you need to schedule patient visits during this period, please contact Cerba Research to determine if any solutions can be determined.

Courier Service Schedule / Customs

As all couriers (standard as well as premium) may have restrictions, please contact them well in advance to check the following:

  • The possible shipping days and possible earlier last calling / pick-up times.
  • Couriers will typically not pick-up or deliver on public holidays.
  • Take your sample transit time into consideration; 24, 48 and 72 hours – to ensure samples arrive the day before a Closure Day.
  • Customs closing times (Only applicable if a pro forma invoice is required).
  • Potential transit delays related to COVID-19 and plan accordingly, particularly for international shipments.

Cerba Research will be providing continuous service during the holiday period (except on the closure days), so please contact us via the study specific email address or via the general contact details if you need assistance:

Cerba Research Europe [email protected]
Cerba Research USA [email protected]
Cerba Research Australia [email protected]
BARC South Africa [email protected]; [email protected]
SRL Japan [email protected]; [email protected]

Thank you for your support and collaboration with Cerba Research. We wish you a safe and peaceful holiday season and new year.

Warm regards,

Cerba Research

Communication on Coronavirus (COVID-19)

Cerba Research is closely monitoring updates related to COVID-19 and will implement processes to ensure smooth running of all biomarker, central laboratory and in-vitro diagnostics services during this time, as needed. These processes are focused on the well-being and safety of our employees, our customers, investigator sites and the participants.

As of today, we are continuing to operate as normal; Cerba Research is in close communication with couriers to ensure timely follow up of collection and transportation of test samples and will communicate for affected areas where needed.

According to the World Health Organisation (WHO) Director General’s Opening Remarks at the weekly mission briefing on COVID-19 on 4th March, the WHO has raised its assessment of the risk of spread and the risk of impact to very high at the global level. This link provides more information from the briefing.

In response to this assessment;
• Actions have been taken to protect Cerba Research staff and ensure business continuity.
• Cerba Research have implemented a travel advisory and all employees globally will not be permitted to travel, unless extreme circumstances require it.
• All employees have received training and guidance on personal protection measures.
• Regular internal and external updates will be provided as needed as we continue to monitor the situation.