"Akela’s SOPs have been written to a good standard and in compliance with the requirements of ICH GCP and the applicable regulations. Based on the review of the monitoring reports for both client studies, Akela have followed the approved SOPs and reported the monitoring visits to a good standard".
- Extract from audit report by Independent QA Consultant, July 2009
"I have been working with Akela for the last three years. Clare first managed a trial for us in the UK and Sweden, which was challenging, but ultimately successful. Being based in the West coast of the USA I needed someone I could trust with my study. When we decided to run a second trial in the UK, Akela was the obvious choice of CRO. I particularly like the way they proactively managed the studies, keeping me informed as needed, making clear requests of me and being highly responsive. Clare and the Akela team forged excellent working relationships with all of our investigators and collaborated well with third parties too. We were especially happy that Clare was on-site for our FDA inspection last year; her daily updates meant that we knew how the inspection was going in real-time, which reduced our anxiety levels considerably! The inspection produced no findings which is testament to the quality of Clare's monitoring and management. I would have no hesitation in recommending Akela in the future".
- Dr Jeff Gregory, Chief Medical Officer, MediQuest Therapeutics Inc
"We selected a new site to participate in one of our trials. I was pleased when this site independently hired Akela to help them initiate and manage the study. Knowing that Clare and John were involved increased my level of comfort from the outset as I knew of their work from WCT. My CRAs and medical monitor have been impressed with the speed of recruitment, quality of the data and Clare's coordination of the site. Recruitment at this site actually proved better than at the more experienced sites on the study so we awarded a second trial to them. In my opinion Akela's input made a positive contribution to our trial."
- Geoffrey Dunbar M.D., Vice President, Clinical Development and Regulatory Affairs, Targacept Inc.
"I got to know John Matthews in 1997 when he was appointed as the Global Project Manager from Worldwide Clinical Trials for Novartis Pharmaceuticals' landmark Suicide Prevention Trial (InterSePT), the successful execution of which led to a new indication i.e. "suicide" being created. In this exceedingly complex trial with multiple endpoints, numerous assessment measures and a database consisting of over two million data points, John led a multidisciplinary team of over 100 CRAs, data managers, statisticians, regulatory staff, etc., and successfully locked the database on time.
Based on his past performance, I have the utmost confidence that John will ensure that Akela will produce similar results in the future. I have assigned John the Project Manager responsibilities for a first human administration trial in patients with Alzheimer's disease. I am sure John will ensure that site selection, monitoring, study documentation maintenance will be performed to the highest standards.
I have no hesitation in recommending Akela for performing Clinical Research oversight activities."
Ravi Anand, MD. VP Clinical Development ENKAM Pharmaceuticals
and Independent Consultant, Basel Switzerland.
"I had the pleasure to work with both John and Clare in my previous position as International Head of the CRO WCT, which was later to become i3 Research. They both worked for me in different functions over a number of years and I grew to place much trust in them. WCT has reformed and I have already asked Clare and John to support us providing a number of operational services, which they delivered in amazing time and quality.
In my opinion John is one of the best senior project managers I have worked with. When WCT were assigned the InterSePT study he was the natural choice to lead the international team of over 100 staff and he did not let me down.
I personally invited Clare to move from clinical operations to business development as I recognised her ability to manage client relationships; I believe I made the right choice. Years later I am delighted that they decided to work together and I feel that their combined skills will ensure Akela's continued success. I am sure WCT will need high calibre consultants from time to time in the future and Akela will be one of my first choices".
Angelico Carta, MD. President, Worldwide Clinical Trials (WCT)
"Clare and John were recommended to me and have recently monitored and managed three phase I/II studies for Vantia Ltd. I found their flexible approach a great asset and our trials were set up and started in rapid time. Clare and John's work was of the highest quality and I felt fully informed throughout the trials. Issues that arose at site level were handled professionally and in a timely manner. Their monitoring reports were excellent. The Phase I / Clinical Study Units were encouraged and motivated by Akela and produced excellent results. I recently commissioned an audit of Akela's SOPs and they passed with flying colours. All in all it was a very successful collaboration and I am more than happy to recommend Akela".
Dr Hilary McElwaine-Johnn, Chief Medical Officer, Vantia Therapeutics
Telephone enquiries: +44 (0) 1837 82165