We focus on translating the scientific hypothesis into a disease setting in man, helping with indication selection and endpoint selection based on the preclinical data package. We also focus on indication selection earlier in the discovery process, considering clinical positioning, true unmet medical need and clinical feasibility early to drive the design of an appropriate preclinical package.
Our Services
Science & Strategy
Translational
science
Clinical
development
We design trials which maximise the value of the data generated whilst reducing the clinical risk. We consider factors such as patient stratification, interim data to give a go/no-go signal and flexible trial design to obtain patient data earlier as part of the broader clinical strategy. We work with specialist statisticians to tailor patient numbers to give a reasonable chance of a scientific signal.
Regulatory
expertise
We advise on the regulatory strategy for companies, defining the product positioning and development pathway. We assist with the interactions with the regulatory bodies both in Europe and the US (EMA, MHRA, FDA). We can provide support and guidance through key regulatory interactions such as seeking scientific advice, pre-IND meetings, applying for Orphan Drug Designation and designing Paediatric Clinical Development plans across these jurisdictions.
Scientific
advisory boards
We bring together leading experts in the relevant therapeutic area to answer key questions at different stages of the development process. Whether this is indication selection, pressure testing clinical trial designs or positioning with regulators or prescribers, engaging with the right external experts can provide substantial support throughout the development process.
Due
diligence
Innovation within biotech continues to be driven by the acquisition of smaller biotechs by larger biopharma companies. We provide an independent perspective on the translational science and the risk/benefit balance for companies or assets being acquired using our bespoke framework. This relieves pressure from the internal team and is supplemented by our broader network of KOLs.
Company
creation
We work with entrepreneurs and academic founders to build the scientific hypothesis around which we develop an operating and funding plan to raise investment. This includes pressure testing the key risks with our partners on intellectual property and commercial and competitive positioning. Our flexible consulting model allows early stage company to pull in relevant expertise as needed before having to commit to full time hires.
Clinical Excellence
Clinical
trial feasibility
We consider site selection, including specialist centres where needed. We identify and engage chief investigators and principal investigators as needed, consider costs and timelines to deliver trials, including pressure testing patient recruitment estimates.
Choosing
the right CRO
We develop requests for proposals with the company, identifying the key factors that are unique to the trial, company team, budgets and timelines. We will recommend a number of different CROs to contact to prepare a bid, review the bids, attend pitches and question the CROs to identify key risks and prepare a recommendation for the company’s selection of a CRO.
Oversight
of clinical studies
We can provide a part time or full time experienced clinical development team and clinical operations team to oversee the CRO and ensure your studies and plans remain on track. This can include as appropriate, Chief Medical Officer, Chief Development Officer, Clinical Operations Lead, Study Manager, Project Manager, and Site Monitor.
Quality management systems
We work with our clients to put the appropriate quality management systems in place, including the development of standard operating procedures for the clinical phase of activities, training on best practice and oversight and implementation of pharmacovigilance safety reporting systems.
Our differentiators
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.
We possess expertise across multiple therapeutic areas, with more than 500 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.
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
success
With a portfolio of clinical trials in 16 cities and 11 countries, our thoughtful design and integrated approach can chart your fastest path to efficacy in patients.
500+ years’
experience
Blending more than 500 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, EMA, FDA, and PEI.
Therapeutic
areas
Our expertise spans more than 15 therapeutic areas, which is augmented further by our network of KOLs.
Questions?
Get in touch.
Biotech consulting
Sophie Baillie
[email protected]
Due diligence
Stuart McGuire
[email protected]