Phase II Clinical Services

Looking for an experienced CRO for your phase II clinical study? Simbec-Orion provides fully managed phase II CRO services, as well as stand-alone study design, biometrics, central laboratory support and more.

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 phase I and 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 can establish a strategic phase II trial design that foresees challenges to mitigate risk. By establishing your goals, the phase II trial design will meet your objectives while prioritising patient welfare.

Our 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 rare disease and oncology clinical trials; we’re experienced with recruiting patient groups from small cohorts. 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 experience recruiting patients for phase II trials, including for 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. We’ve dealt with these before. Rather than having to generate brand new resolutions, we’ve established tried-and-tested solutions to any problem your phase II trial could encounter.

As a small, full-service CRO, you get the benefit of an attentive and reactive clinical service, with the experience and resources needed to see a phase II trial to completion.

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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