My Services
I’ve worked in the Pharmaceutical Industry for over 20 years, working for companies such as GlaxoSmithKline and Huntingdon Life Sciences. I have a passion for supporting drug discovery and development through the method development and validation of robust bioanalytical assays for small molecules, their metabolites and biomarkers, troubleshooting and solving complex bioanalytical assays and training and mentoring junior scientists. I can work independently and as part of a matrix team.
I can support your team with one, or any combination, of the below services.
If your requirements are outside of these areas, please don't hesitate to contact me to discuss how I can support you.
Method Development
As a bioanalytical expert, I have developed numerous assays across a range of compounds with varying complexities, for the quantification of small drug molecules and biomarkers. I am able to provide the in-house technical expertise necessary to develop low picogram assays to support PK and PD studies for key decision-making and, if required, I can also provide training for less experienced staff.
Method Validation
When undertaking studies that will be subjected to regulatory submissions, key steps and processes must follow specific guidelines and industry standards, as set out by the EMEA, ICH M10, prior to submission. Ensuring that the method validation is compliant and successfully audited will contribute to the successful delivery of the project objectives.
Protocol Review, Data & Report Checking
The goal in reviewing the bioanalytical aspect of a study is to ensure the collection, storage, sample volumes, transport, sample treatment and handling are consistent with the validated method to ensure data integrity. Inconsistency and errors in data and report checking can impact the final results and study interpretation and therefore can cause inaccurate decision-making.
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