Phase II Clinical Services

Local support for your Phase II trial across Europe and North America

Looking for an experienced CRO for your phase II clinical study? Simbec-Orion teams are based throughout Europe and North America, and provide fully managed phase II CRO services, as well as stand-alone study design, biometrics, central laboratory support and more to its biotech and pharmaceutical clients.

Our phase II clinical services include:

  • Fully managed phase II clinical trials
  • Trial design
  • Pharmacovigilance, biomarker studies, scintigraphy, rescue studies and other designs
  • Experienced project managers and Clinical Research Associates (CRAs)
  • An understanding of the complexity of trials from sponsorship to patient care
  • Specialism in oncology and rare disease

As a full service CRO, we also offer comprehensive phase I to phase III clinical trial management services.

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Phase II Trial Design

Phase II is, arguably, the most challenging phase of your drug’s development. It represents a critical point in determining a drug’s cost and securing sponsorship to continue product development.

At Simbec-Orion, we will establish a strategic phase II trial for your drug that foresees challenges to mitigate risk. By considering your goals from the outset, we ensure that the phase II trial design will meet your objectives while prioritising patient welfare.

Our deep and extensive experience in phase II design and execution means we’re familiar not just with common challenges, but also their solutions. We can design a targeted phase II trial that’s adaptive, strategic and attentive.

Phase II enrolment

Phase II is the first point at which your drug is tested in a group with the target condition – bringing about new challenges in recruitment.

Simbec-Orion specialises in oncology and rare disease clinical trials; we’re experienced with recruiting patient groups from limited and disperse populations. Part of this begins in the phase II trial design, creating an attractive study more likely to engage patients. For example, we can run decentralised trials where suitable. These promote recruitment by limiting travel requirements and making the trial more accessible.

We have decades of experience recruiting patients for phase II trials, including for oncology, rare oncology and rare or ultra-rare disease studies.

Phase 2a and 2b studies

We can run both phase 2a and 2b clinical trials, as well as trials with a range of objectives and methodologies.

Phase 2a, proof of concept studies, and Phase 2b, definite dose-finding studies, come with unique requirements, objectives and challenges, which we have come across many times. Rather than having to generate brand new resolutions, we’ve established tried-and-tested solutions to any problem your phase II trial could encounter.

Our clinical teams across Europe and the USA are local to and have strong relationships with, leading research sites across the globe including large academic sites. Over our 25 years of conducting late-phase clinical trials, Simbec-Orion has developed a robust foundation of expertise, site-level knowledge, and relationships that are the foundation to successfully managing trials. We command the regulatory intelligence and expertise to initiate trials within Europe, the US, and across the globe, complimented by local nuances such as site contracting requirements.

A full service CRO

As well as phase II, Simbec-Orion offers phase I and phase III clinical services, plus biometrics, central laboratory services, protocol writing and more.

With Simbec-Orion, you can build a lasting partnership. Our reliable project managers and CRAs can take your drug’s development through every step of its journey.

Let’s collaborate

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

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