From protocol design and development through data lock, AKESOgen’s Genomic Clinical Trials Services can partner with you to ensure that your project goals and deliverables are achieved – from pre-clinical through Phase IV. We understand the pressure to expedite trials, reduce time and cost, and do more in fewer trials.
Each clinical trial is unique and we have the ability to quickly adjust to study changes and amendments that are commonly needed as part of the clinical trials process. AKESOgen’s network of resources can advise on any country-specific global challenges early in the process to prevent delays that impact your timeline.
Our scientific and operational expertise can advise on the selection of appropriate assays and methodologies and key operational aspects that can impact your budget.
From an assay point of view, AKESOgen can design, develop and validate biomarker assays tailored to the trial needs. These assays can focus on any disease or therapeutic area and include genomic and ‘personalized medicine’ assays.
Your Project Manager will develop a protocol-specific project plan ensuring that all staff assigned to your project are trained in any procedures specific to your protocol. Custom requirements are supported by appropriate documentation, SOPs, milestone reporting and monitoring activities.
Your data and reporting requirements are discussed in detail and sent to you in a client-approved format.
We are available throughout the clinical trial for consultation and study review and will ensure that we provide to you any documentation required for your regulatory submission.
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