Phase II
Clinical Services
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 and consultancy
- Pharmacovigilance, biomarker studies, scintigraphy, rescue studies and bespoke designs, clinical operational support, and site monitoring
Our experienced teams of Project Managers and Clinical Research Associates (CRAs) across Europe and North America, will work closely with your teams, bringing with them a deep understanding of the inherent complexity of phase II trials.
As a full-service CRO, we also offer comprehensive phase I to phase III clinical trial management services.
Phase II Trial Design
Phase II represents a critical point in the development of your drug, often securing sponsorship to continue product development.
With a flexible approach that always keeps your deadlines and budget in mind, the expert scientists at Simbec-Orion will design a strategic phase II trial for your drug that anticipates challenges so as to mitigate risk.
Solid foundations are established through a robust feasibility process. In conjunction with this, your study design will be developed with input from not only our own Medical Directors but also our independent Scientific Advisory Board along with Key Opinion Leaders in the relevant field.
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 trial design and execution means we are familiar with the common challenges, as well as their solutions. Often working with patients from populations that are geographically diverse, we have conducted studies that incorporated patients from regions as far apart as northern Europe and South America. You can be assured that we will design a modular and targeted phase II trial that’s adaptive, strategic, and attentive to detail, delivering the data you need.
Phase II enrolment
Phase II can be the first point at which your drug is tested in patients with the target condition – bringing about new challenges in recruitment.
Simbec-Orion specialises in oncology and rare disease clinical trials. With decades of experience recruiting patients for phase II trials, including for rare or ultra-rare disease studies, and established links to patient advocacy groups and key opinion leaders around the world, we are highly experienced in recruiting patients from limited and disperse populations.
Starting with the phase II trial design, determining the right recruitment strategy and patient pathway on a site-by-site basis is critical to creating an attractive study that will engage patients and facilitate both participation and retention. We can build in decentralised elements, such as home visits from mobile research nurses at a day and time convenient to the patient, in order to minimise disruption and enable participation.
Phase IIa & IIb studies
Simbec-Orion designs and delivers both phase IIa and IIb clinical trials with a range of objectives and methodologies.
Phase IIa, proof of concept studies, and Phase IIb, definitive dose-finding studies, come with unique requirements, objectives, and challenges that we have come across many times. Rather than having to generate brand new resolutions, we have established tried-and-tested solutions to any problem your phase II trial could encounter.
Our local clinical teams have strong site relationships with leading research sites across the globe, including large academic sites. Over more than 27 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, complemented by local nuances such as site contracting requirements.
A full service CRO
In addition to phase II trials, Simbec-Orion offers fully integrated phase I and phase III clinical services, plus biometrics, central laboratory services, protocol writing and clinical operational support, monitoring and pharmacovigilance.
Our established and stable teams mean that our partners can confidently create a lasting partnership with Simbec-Orion. We continuously strive to build trust, through open and transparent communication pathways, always employing a one-team approach, with quality and transparency built in from the start.
Establishing a longer-term relationship across different phases of your drug’s development allows us to synchronise and streamline program elements such as contractual processes, vendor selection, communication, transfer of data and information etc., and accomplish both time and cost efficiencies across your development program.
Together, we can take your drug’s development through every step of its journey.
What our
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations
Klaria AB
