Oncology CRO Services

Phase I-III oncology expertise

Simbec-Orion has the experience and resources to provide exceptional oncology CRO services from conception to delivery.

We know that oncology drug development requires flexibility, determination and engaged study sites with close management. Trained in their therapeutic area and the specifics of your study protocol, our CRAs are regionally based. We provide a flexible, cost-effective and fully integrated approach to oncology clinical trial development and execution.

We have experience conducting Phase I/II adaptive oncology clinical trials, through to Phase III rescue studies. Our deep understanding of managing complex hospital-based studies, supported by a world-leading oncology advisory board, ensures we deliver exceptional CRO services every time.

What to expect from an oncology CRO

One team, together

A successful CRO doesn’t operate separately from your team, but works with you to meet the needs and specific requirements of your oncology clinical development programme. We listen to your needs as a business, the questions you’re trying to answer, the challenges you anticipate and the resources you have. From here, we develop a programme to suit your goals.

In-depth understanding

Everyone involved in your project from Simbec-Orion will have in-depth knowledge of the appropriate complex protocol. The CRAs working on each project are specifically assigned according to their specialities in oncology. This ensures they understand the ins-and-outs of the therapies and treatment modalities involved in the programme.

Blending of the commercial & human

No oncology clinical research programme is separate from the human needs nor the business goals. At Simbec-Orion, we understand both. We take into account the commercial aspects and the human needs. We can then deliver oncology development programmes that make a difference to people, care for patients and work for your company.

We work for patients and deliver on your business’ needs.

Full oncology trial delivery

At Simbec-Orion, we specialise in working with you from the ground up. We design and implement oncology clinical trials from conception to completion. We have experts in early phase oncology trials through to phase iii, and experience delivering on every stage of clinical development for oncology.

We listen to your needs and requirements, then come up with a plan. This involves designing oncology clinical trials, sourcing appropriate clinicians and institutions, and managing the programme.

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

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. View the case study.

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

Read here

Case Study

First in patient oncology 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 product types including vaccines, new chemical entities (NCEs), antisense therapy, small molecules, peptides, antibodies, genetically modified organisms (GMOs) and biologics, and gene therapy. Whatever the focus of your oncology clinical trial, we can deliver.

Let’s collaborate

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

Submit an RFI/RFP