Committed to the success of your clinical trials, Actaphase’s team of professionals provides specially tailored solutions to meet the needs of your clinical trial.
Study Start-up
Starting a clinical trial is a substantial process, which we take seriously. We know clinical trials have tight deadlines, so we plan everything carefully from the beginning until the end.
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Regulatory Affairs
Navigating the rules and regulations for clinical trials is a crucial step, and our team is right there on the ground, handling the details and meeting the requirements of the regulatory and ethics authorities.
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Import and Export Licenses
Actaphase offers crucial support in obtaining Import and Export Licenses
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Translations and Adaptations
This service aims to ensure that all participants, stakeholders, and regulatory bodies can access accurate and consistent information, regardless of language barriers.
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Amendment and Notification Submissions
Actaphase can provide essential support in the process of submitting amendments and notifications to regulatory authorities during clinical trials.
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Site Management
Our procedures and tools are designed to begin with selecting the right sites, ensuring our projects' site network remains untangled and highly organized. In Site Management, we empower our CRAs to take the lead.
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Warehouse and Logistics
Logistics in clinical trials, especially concerning investigational products (IP), are crucial to ensure the safe, efficient, and compliant handling of drugs or devices being tested.
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Clinical Trial Monitoring
Trust our expertise to streamline site selection and setup, setting the foundation for a successful clinical study.
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Quality Assurance and Quality Control
A Quality Plan is a comprehensive document that outlines the strategies, processes, and standards for maintaining and ensuring the highest level of quality, accuracy, and regulatory compliance in the services and activities related to clinical research and trial management.
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Trial Master File (TMF) Management
The Site Master File (SMF) is a comprehensive document that contains essential information about a clinical trial site.
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Essential Documents Management
Effective management of essential documents is crucial in clinical trials to ensure data integrity, regulatory compliance, and the overall success of the study.
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Safety Management
Adverse events and Serious adverse events are already known as potential risks when participating in a research study with a specific investigational product.
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