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.
How I can support you
As an expert in bioanalysis I can provide continued, dependable support to include timely protocol review, data and report checking of validation and sample analysis studies.
I can support you with all of these tasks, or individual elements of your checking requirements.
Case study - Protocol Review, Data & Report Checking
I was responsible for the method development, validation, protocol review, data checking and report writing of the First in human study for Alpibectir (BVL-GSK098), a novel potent anti-TB drug.
What I did
I reviewed and provided feedback to the Project Representative on the possible impact of the validated matrix factor on the data generated.
I achieved this by:
- Reviewing the calibration and quality control data to ensure the acceptance criteria were met for each analytical run
- Reviewing the report to ensure any deviation or unexpected events were captured and addressed
- Ensuring the sample analysis was carried out within the validated stability period ensuring data integrity
- Ensuring all relevant documents, e.g Certificate of Analysis, were included and within their expiry date
How I did it
The determined concentration of BVL-098 in human plasma contributed to the published article for which I was acknowledged for the bioanalytical support in the sample analysis and scientific advice and expertise.
Result
The successful results of this method can be seen in this publication.
Publication
Other Services
Method Development
As a bioanalytical expert, I have developed numerous assays across a range of complexities for the quantification of small drug molecules and biomarkers in biological matrices. 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 train your teams on my methodology.
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.
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