Simbec-Orion Case Study: Oncology

CASE STUDY THERAPY AREA: ONCOLOGY RESCUE STUDY, WORKING ALONGSIDE A MEGA CRO TO RESOLVE SITE ISSUES ON MAJOR ONCOLOGY STUDY.

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CASE STUDY SPONSOR OBJECTIVES: During the study, the sponsor became suspicious that they were not seeing a normal level of background noise in the study – particularly protocol deviations.

Because of the sponsor’s previous experience of working with Simbec-Orion, we were invited to re-monitor a percentage of the work already monitored by the CRO initially contracted to perform the study.

CHALLENGES OF THE STUDY •

Large Phase III study initiated with a mega CRO

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Site Issues Lead

PATIENT PROFILE 800 patients with locally recurrent or metastatic breast cancer

STUDY CHALLENGES: Our initial review confirmed that there were substantial issues with the site in question – in particular the level of source data verification did not appear to be rigorous enough.

We were asked to examine more sites and review the RECIST assessment of tumors •

We found that there were errors in the data being collected

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We estimated that just less than one-third of sites had problems

Due to the size of the study, the sponsor wanted to continue the relationship with the mega CRO, but wanted Simbec-Orion to work alongside them to resolve the issues identified.

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CASE STUDY OUR SOLUTIONS: Simbec-Orion set-up a team of senior, highly experienced CRAs (Clinical Research Associates) to attend sites alongside the existing site monitors, which required tact and diplomacy from our side.

As a result of this preliminary work •

re-monitoring was extended in selected areas

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re-monitoring of tumour assessment data for a percentage of patients was requested

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one site (highest recruiting site) was judged to require 100% re-monitoring

We identified one site where we and the sponsor were concerned there were signs of fraud, with constantly changing data between visits.

We worked hard with the other CRO’s CRAs to develop a relationship and develop a rapport.

We developed in to a mentoring role, training often junior CRAs. The junior CRAs eventually welcomed the presence of the more senior CRA’s to guide and offer experience.

We conducted a 100% retrospective re-audit and re-SDV of all information from the potentially fraudulent site.

Our concerns remained that the site might be taking the fee without doing the work and significant data was found in the patient records which had not been uploaded to the eCRF. Based on this we then undertook a second Site Initiation Visit (SIV) for this site and retrained all staff. The added attention remediated behavior at the site.

Once additional attention was applied the study then proceeded positively to completion and the sponsor was pleased with all parties’ involvement including our fellow CRO.

RESULT FOR CUSTOMER: Simbec-Orion’s high quality monitoring by mature and experienced CRAs assisted in ensuring that this large phase III study provided high quality, publishable data to support the further development of the drug.

This helped the sponsor get the project back to original timelines. The study ultimately was a success after the rescue period and all parties are satisfied.

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MISSION STATEMENT We are Simbec-Orion. An international, full service, boutique CRO; growing by bringing together the best possible people, healthcare professionals and drug developers, from all areas of clinical development.

We focus on a defined series of core therapeutic areas, where we can make best use of our skills elegantly to design, execute and deliver our clients’ clinical development needs.

We are making Simbec-Orion a highly respected and profitable boutique CRO. We do this by working for our clients with excellence, commitment and passion for our trade. We provide an environment in which our colleagues can continue to grow and develop.

We will always remember that our work leads to the improvement of patients’ lives

To find out how Simbec-Orion can help with your clinical development program email info@SimbecOrionCRO.com Or call our business development team on +44 1753 578080 FRONT COVER IMAGE: CLASSIC INVASIC LOBULAR CARCINOMA OF THE BREAST, SIGNET RING CELLS.

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