Akela offers personal attention, continuity and accountability. Short set-up times and rapid response are key elements in our service.
Akela combines market awareness with independence, enabling us to give unbiased advice on matters including investigative site selection and vendor proposal review.
Not only does our past industry experience give us skills and credibility but it has also exposed us to numerous contacts including senior pharmaceutical professionals able to advise on regulatory, statistical and programme design, notably in anti-infectives, CNS, oncology and HIV. We rely on our contacts to quickly form a full-service team of providers to meet your trial needs.
Past industry experience has been gained in big pharma, CRO and the central lab environment.
Akela has worked on numerous multinational trials in different phases and multiple indications.
Akela has participated in a US client’s NDA FDA inspection preparation, interviews and site training. Prior to this Akela participated in a UK client’s routine MHRA GCP inspection preparation, interviews and site training.
Akela maintains a large network of expert contacts and trusted collaborators.
Interim Global Head of Clinical Operations – TM Functional Services Ltd
- Headed up a new CRO to enable a new permanent director to take over the department requiring immediate strong management to reassure the client that the new team were up and running immediately whilst managing the transition of a complicated trial from another large disgruntled CRO. Excellent communication skills essential to manage the new European team, QA consultants, the departing CRO and both the new CRO & client boards. Strong people management and KPI delivery were key strengths.
- Championed recruitment strategies devising investigator presentations and travelling to sites where C-19 permitted, or virtually, resulting in the expedited delivery of more patients.
Senior Director of Clinical Operations – Curium Pharma Ltd, London
- Led a Named Patient Compassionate Use of a radio-labelled drug for prostate cancer treatment. Managed all EU General Managers/Market Access Leads, reported directly to the board resulting in sales increasing above target across all territories.
Vice President, Global Client Solutions, Syneos Health Ltd, Farnborough
- Led a large new pharma partnership implementation ($1Billion). This included responsibility for defining partnership process framework and leading, via matrix structure, all work streams in both the top 10 Pharma company and Syneos to ensure all ‘Systems, Processes, Tools & People’ were defined to deliver the highest quality clinical service.
- Defined the Governance structure, establishing pillars of understanding, an integral part of a successful group of executives tasked to orientate both teams on corporate structure, culture, goal alignment, crystalise partnership vision and reinforce commitment.
Interim Director, Clinical Operations, Shionogi B.V., London
- Asked back as EU Director of Clinical Operations (previously Director 2014-2016) overseeing the EU management of the key antibiotic Fetroja (cefiderocol) and also the main liaison with senior management in US & Japan’s headquarters. Both studies recruited early.
- Set up QC team to ensure company was inspection ready for the two global trials managed.
- Led the clinical team, as requested by QA, in the ‘back and front’ rooms at six mock and actual MHRA, FDA and EMA inspections. Employed forensic skills to help train staff to know how to answer inspectors’ questions and to manage silence.
Highly Active Anti-Retroviral Therapy Oversight Committee, HAART-OC
- Managed monthly telephone conferences and bi-annual meetings for this prestigious group for 16 years. HAART-OC consisted of very senior managers from six of the MAH holders of HIV products. Produced detailed peer reviewed minutes that were sent to the FDA/EMA.
Parexel International Limited, CRO, Uxbridge
- Senior Global Project Leader managing a global phase I biosimilar Rheumatoid Arthritis trial (€30M): 17 countries – study made up of two parts with extension study.
- Revamped monthly budgets sent to senior management, forecasting profitability and adhering to agreed sponsor timelines. Managed 4 Clinical Operation Leaders.
- Interim Senior Project Leader managing a global phase III multiple myeloma trial (€46M).
Anaxsys Technology Limited, Send, Surrey
- Senior Project Manager achieving success in a multicentre respiratory device trial including a paediatric population. Product successfully launched in many hospitals.
Antisoma Research Limited, London
- Interim Project Manager of phase I oncology trial. Assisted in protocol writing and CRO selection. Trained new team, who are now successful Senior Managers themselves.
Cancer Research UK
- Interim Project Manager of three phase I trials in the UK, assisted in protocol writing.
- Managed a phase I osteoporosis study for an Australian biotechnology company
- Qualified sites for a phase I CNS trial for a UK biotechnology company
- Led a team to produce a full set of global SOPs in two months after the acquisition of four companies by a large CRO
While we have the advantage of a broad network of contacts, Akela is not aligned with any other enterprise.
This allows us to offer you:
A different perspective
When you are managing a project you need your sub-contractors to be accountable. Akela offers:
Continuity of staff
A responsible and solution-driven work ethic
Time is always of the essence in clinical research. Akela has:
– No hierarchy
– Fast decision-making
– Swift implementation
– Rapid response to clients
Overall clinical trial delivery requires the successful management of risk, not simply identifying the risk but managing it so that it does not materialise. Often the global development teams are virtual, through CROs or across many countries. This requires excellence in communication; never underestimate how little other people have heard or understood (including international teams) and recognise that there are not necessarily right or wrong answers. There is always uncertainty in clinical development but decisions have to be made based on the best overall body of evidence. A forensically trained mind is a tremendous asset to deliver on this