Oncology Clinical Trials

Phase I-III oncology expertise

Our experience in conducting Phase I/II adaptive oncology clinical trials, through to Phase III rescue studies has given us a deep understanding of managing complex hospital-based studies, supported by a world-leading oncology advisory board. We capitalise on this with trial designs and analytics panels that provide more data from your study. Delivering the information you need to achieve your milestones and transition to that all important next step of your drug development program.

Oncology Clinical Trial Experience - Simbec-Orion

In-house oncology clinical development experts

Oncology drug development requires flexibility and determination at study sites with close study management guidance. Our team of clinicians and scientists will support your clinical development strategy with:

Trained by Board-Certified oncologists in the therapeutic area and the specifics of your study protocol, our Clinical Research Associates (CRAs) are regionally based, for a flexible, cost-effective, and fully integrated approach.
Clinical research specialist medical personnel, regulatory experts, and project managers with extensive practical experience in managing the most challenging oncology studies, ensure quality of data as well as speed of delivery
Our analytical scientists provide customised central laboratory services. Both standard and bespoke assay panels, including an extensive range of validated biomarker assays are available, and can be tailored to the specific needs of your development program.
Decades of interactions have provided extensive experience in obtaining clinical trial approvals internationally
Preparation and submission of requests for Pre-IND and EMA scientific advice / protocol assistance meetings
Attendance at meetings with regulatory authorities
Data-driven, optimised site feasibility assessment process
In-house specialised legal team works with global investigative sites

Through our trusted partnerships we can support:

Cell analysis and imaging to include Flow Cytometry
Next Gen sequencing
PCR
Genomics
Immunohistochemistry and In situ hybridisation

Access to external expert panels & oncology investigators in Europe & North America

Established relationships with opinion-leading oncology clinicians, from both North America and Europe
Access to more than 25 cancer centres and university hospitals through the Oncodistinct Network: Created in 2015, the Oncodistinct Network is a multidisciplinary group of investigators with an expertise in early drug development and clinical research. Their aim is to address the current challenges in oncology and improve patients’ outcomes by developing innovative clinical studies and accelerating the development of anti-cancer drugs in solid tumours, particularly in settings with unmet medical needs.

Exploit the breadth and depth of our experience

For more than 25 years, the scientists at Simbec-Orion have managed clinical trials over an extensive range of tumour types, and with all classes of product including, new chemical entities (NCEs) – small molecules, biologics (antibodies, peptides), cell therapy (genetically modified organisms -GMOs), vaccines, antisense and gene therapy. By tapping into this experience, we can support your goals helping you to drive your development program forward

Agility and resilience

Our size and low-hierarchy management structure makes for agile, flexible processes and allows us to rapidly respond to challenges or escalate issues quickly when required.
For example, a study was needed to ensure first-in patient success in Europe – in a highly competitive oncology field amongst sites and patient availability. There was also a minimum enrolment of 42 patients required to complete the study.

Through a combination of strong site relationships, optimised study design, agile cohort expansion and forward thinking IMP management, we helped our client communicate the results to the scientific and business communities earlier than anticipated with a larger data set of 90 patients rather than 42 patients originally planned.

Your oncology study: from conception to delivery

Alain Thibault, Chairman of the Oncology Advisory Board

With 24 years of experience in oncology study delivery, our expertise enables us to successfully combine your business needs with those of the patients. Discover how.

Case Study

Phase III rescue study, in patients with locally recurrent or metastatic breast cancer.

Read here

Case Study

First in patient study, in patients with relapsed/refractory Non-Hodgkin’s Lymphoma and relapsed/refractory CLL.

Read here

Oncology webinar

If you missed our live Precision Oncology: An Era that Calls for a New Model for Conducting Clinical Trials webinar discussion, you can view on demand now. What have we learned in the past five years, how do we design oncology trials in light of this new information, and how can we improve performance of oncology trials?

Watch now

Drug types

We have managed clinical trials with all products types including, vaccines, new chemical entities (NCEs), antisense therapy, small molecules, peptides, antibodies, genetically modified organisms (GMOs) and biologics, and gene therapy.

Let’s collaborate

If you think we could be right for you, get in touch.

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