CROs

CROs

With so many outsourcing options available for sponsors, we understand the importance of being able to offer a unique and distinctive service, whether that be by geographical reach or therapeutic specialism, the ability to offer a tailored and flexible service has never been more important.

 

We support CROs worldwide, assisting with local and international clinical trial requirements, ranging from bid-defences, INDs and clinical development plans to market authorisation applications and product launches. In locations where you have a limited expert knowledge base, we can provide support throughout The Americas, Europe and APAC, often acting as a transatlantic or pan-European gateway into new regions.

 

 

Bid-Defences

 

Working with Upsilon Global enables CROs the opportunity to use our global contractor network to bid for previously out-of-reach studies. We can support your bid-defence process through the provision of clinical study teams based on the specifics of your sponsor’s RFP.

 

We acknowledge that not every bid-defence is successful, and that it can be a bit of a numbers game, so our charges are only applicable for successful study bids once your ready-made, pre-approved and pre-costed project team starts working for you.

 

Through this service, we assist our CRO partners in competing with larger competitors and present a unique and tailored clinical study offering, resulting in a more targeted and specialised bid-defence, greatly improving the chances of a successful study bid.

 

Local Expertise

 

As the life-science industry continues to develop, so do the regulatory and ethical requirements of studies being submitted to the FDA and MHRA. It has therefore never been more important to understand how to plan, initiate and execute clinical trials in individual countries and regions.

 

As such, Upsilon Global can provide you with local and regional experts who speak the national language, understand the native EC/RA processes and, perhaps most importantly, have existing relationships with local KOLs, sites and PIs.

 

Multi-country Study Teams

 

Upsilon Global offer full multi-country study teams, consisting of a CRA in each country required by the project, and if necessary, a Clinical Project or Study Manager. Each CRA has specific study phase and therapeutic area experience relevant to the drug or device, along with in-country monitoring and EC/RA experience, and of course the spoken language of the country. Where possible, we also ensure that our CRAs are located geographically close to the required sites, to minimise expenses and travel times. All Upsilon Global CRAs are fluent in English.

 

Our model minimises risk and financial exposure for projects associated with a fluctuating schedule of work, allowing you to efficiently ramp-up or scale back effectively as needed.

 

Quality

 

We appreciate that some organisations are unsure about the idea of using an external workforce, and for this reason we make every effort to ensure our contractors are of the highest calibre, have been personally recommended to us, and have all the relevant qualifications, experience and documentation.

 

To centralise control and ensure quality harmonisation, Upsilon Global CRAs are tied to your study guidelines, work schedules and SOPs. We are happy to discuss any specific requirements for individual studies- flexibility and adaptability are hugely important in the clinical trial world, and we understand that every study is different.

 

For your peace of mind, every Upsilon Global contractor comes with the following:

  • Professional Indemnity insurance (€500K)
  • Public Liability insurance (€5,000,000)
  • 3 Endorsements from industry professionals
  • Right to work documentation
  • Academic Qualification certificates
  • Upsilon Global branded and verified profile and work history
  • Ltd. Company / Umbrella certificates (if applicable)

 

We will not send out a contract until a contractor has provided us with this documentation, and we hold copies of all certificates on file, which our partners are welcome to request at any time.