Our Services
Science & Strategy services:
We are focused on translation into patients
Scientific strategy
Indication selection
Asset positioning
Competitive landscape
Clinical development
Trial design
Patient Stratification
Early Efficacy signals
Regulatory expertise
Regulatory strategy
Lead/support regulatory meetings (e.g. EMA, MHRA, FDA)
Orphan Drug Designation
Paediatric Investigation Plans
Scientific advisory boards
World-leading experts
Key questions
Clear advice
Clinical Excellence services:
We embed operational excellence early
Clinical trial feasibility
Site selection
Engaging chief investigators
Assess timelines and quotes
Oversight of clinical studies
Part/full time flexible development team
From C-Suite and CMOs to Clinical Operations Lead, Study Manager, Project Manager, and Site Monitor
Choosing the right CRO
Developing RFPs
Managing bid selection process
Guiding CRO selection and recommending providers
Quality management systems
Implementing quality management systems
Developing SOPs
PV and safety reportingTraining
Strategy & Transformation services:
We maximise value for your business
Transformation
Implementing best practice
Support development of new operating models
Growth
Work in partnership to offer solutions that maximise value
Due diligence
Buy side diligence
Sell side diligence
Independent validation of scientific hypothesis
Company creation
Fundraising
Strategy
Flexible access to expertise
Our differentiators
We possess expertise across multiple therapeutic areas, with more than 900 years’ drug development experience in our team at your disposal.
We can assist with the fundraising process, explaining the clinical development strategy to potential investors.
We are flexible and communicative, with a team leader committed to each client.
We combine an agile biotech mindset with the proven expertise of pharmaceutical drug development.
We partner with our clients on solutions that maximise value.
We offer integrated solutions and embed our team members in your organisation on a full or part-time basis.
Our track record
Client
satisfaction
An above average rate of repeat business and word-of-mouth driven new client relationships reflects the quality of our input and the outcomes we achieve.
Clinical
successes
With a track record of successful clinical trials in multiple cities and countries, our thoughtful design and integrated approach can chart your fastest path to efficacy in patients.
900+ years’
experience
Blending more than 900 years’ experience, we are uniquely positioned to de-risk your programs and maximise value across the drug development lifecycle.
International
reach
We can manage single and multi-centre trials across the world – our current portfolio involves 15 cities across 12 countries, including Brazil, France, New Zealand, Spain, the UK and USA.
Regulatory
wins
We have led multiple defence meetings with regulatory authorities, including the MHRA, FDA, EMA (including CHMP, SAG, COMP and PDCO), MEB, AEMPS, BfArM, and PEI.
Therapeutic
areas
Our expertise spans more than 30 therapeutic areas, which is augmented further by our network of KOLs.