We work with you to deliver now with a view to scale and mature your business toward success:
We focus on working with your teams to maximise outputs and timely delivery of projects. This is all about providing focus and an external voice with a specific target.
We have extensive Prince2, Lean and Agile project management experience, and pragmatically employ the components most appropriate to your immediate and longer-term needs.
The SDLC is one of the most complex, variable, and nuanced areas in a biotech - ranging from single coders to teams in the hundreds. Experience is key in building and evolving away from coding for R&D into best practice, quality driven teams that work efficiently and produce robust products (e.g. under ISO 62304).
We evolve SDLC processes and best practices for every size and shape team, with ownership by the team and with a clear pathway towards audit-readiness and increased team sizes.
We work across regulatory, security (InfoSec), and technical teams to build policies and procedures suitable for your organisation at its current stage of growth. We can run monthly meetings to help maintain risk registers, action logs, and keep accountability high.
Previously we have written and managed policies and processes for GDPR, HIPAA, ISO 15189 and ISO 27001.
Our aim is to improve your outputs today but without sacrificing your ambitions for the future - by managing and building today with experience, you prepare for tomorrow too.
We offer pragmatic advice and will talk through key decisions with you from a variety of viewpoints before you make decisions, so that you can have maximal confidence. This epitomises our evolution-based approach to engage with your teams, and gather their input, give them ownership, and increase enthusiasm as a proven method to success.
We commonly work at the interface between in silico teams and wet-lab-led senior leadership teams, as the expectations, ways of working, and (sometimes) the jargon can impair delivery. Providing that pivot is especially rewarding to improve outcomes and increase understanding.
We have a wealth of experience from small projects through to programmes of work with budgets in the millions, from teams of one (more mentoring) to large hybrid teams mixing on- and off-shore, in- and out-sourcing, fully remote to fully on-site, across multiple time zones, and products used in multiple continents.