Octa Consulting Services partner with pharma companies along the drug development process offering both a bird’s-eye view of the molecule’s journey and a granular focus on statistical methodology. With tailored and researched statistical applications, we offer peace of mind from Clinical Development Plan (CDP) development to regulatory success, affording our pharma clients the freedom to challenge and push their own expectations.
Octa Consulting Services provide design, planning, implementation, and analyses of CDPs or individual clinical trials. From ‘First-in-Human’ studies to regulatory approvals, Octa Consulting Services will work with its partners to ensure a relevant and applicable evolution of the CDP. We have experience in a number of key disease areas including novel or orphan diseases. Octa Consulting Services work in both traditional designs (e.g. 3+3, SAD/MAD, parallel group Phase 3 etc) and also a range of adaptive and/or emerging designs such as the increasingly popular BOIN design in Phase 1.
Octa Consulting Services provide consultancy to project teams on how to prepare for high-stakes meetings such as Regulatory Health Authorities, Due Diligence assessments or whenever the interpretation of data is key. We have provided in-meeting biostats contributions to key Regulatory Authorities, the list of which includes: FDA, EMA, German, Spanish, Swedish, Swiss, Australian, and Japanese. The disease areas most recently supported include Oncology, Haematology and rare respiratory diseases. Octa can provide Due Diligence assessments for collaborations or mergers as well as Quality Inspections or audits of CROs with regards to statistics and statistical programming activities.
In addition to using existing (published) statistical methodology to support consultancy recommendations, Octa Consulting Services will supplement this approach by performing our own research and conducting simulations of different clinical trial scenarios. We have used existing statistical methodology in Phase 1 oncology studies, using traditional 3+3 design and BOIN (Bayesian Optimal Interval) for simulations of ‘First-in-Human’ studies. Octa also perform clinical trial design simulations and analyses using R-programming making use of open-source R packages including R-PACT which provides flexible options for designing studies and sharing results with clients.
In addition, Octa use R programming to evaluate specifically the blinded data in order to inform the best way to analyse the unblinded data. Octa can tailor the programming specifically to the individual context of the clinical trial. This case by case focus makes Octa Consulting Services an ideal partner for pharma companies working in rare or orphan diseases: as novel approaches need to be carved out in new areas. Octa Consulting Services partner happily with existing CRO support, ensuring that the CROs fulfil their brief as Octa provide strategic and focussed direction on behalf of the pharma company.
For those clients wishing to increase their own knowledge of statistical methodology and/or drug development, Octa provide bespoke training in a variety of formats. For example, we use seminars, workshops and (informal) ‘Lunch-n-Learn’ style sessions either through video or face to face. Training packages available include: