From study start-up and regulatory permits to vendor assessments, source data and SOP development, Alpha CR Solutions prepares your sites and study documentation so the first patient can be screened without delay.
The study start-up phase sets the foundation for everything that follows. Delays in regulatory permits, gaps in vendor qualification, or poorly designed source documents create problems that compound throughout the trial.
Alpha CR Solutions manages the full start-up workstream so that your sites are properly contracted, your documentation is compliant, and your vendors are qualified before the study goes live. We support both naive sites running their first trials and established sites expanding their capacity.
Our engineering-informed, systematic approach means nothing is left to chance, and every essential document is in place before site activation.
Get in TouchA complete set of services to take your trial from protocol to an activated, inspection-ready site.
End-to-end coordination of all start-up activities — from feasibility and site selection through contract execution, regulatory submissions and site activation.
Preparation and submission of Material Transfer Agreements and the import and export permit applications required to move samples and investigational products.
Vendor qualification and assessment conducted to your specification, supported by a maintained vendor database for fast, repeatable vendor selection.
Generation and review of compliant source data templates before first patient screening — reducing downstream queries and protecting data integrity from day one.
Development of Standard Operating Procedures tailored to your site or organisation, with ongoing support and version tracking to keep them current and audit-ready.
Hands-on support for naive and established sites — setting up the site, building the Investigator Site File, and coordinating vendor contracts ahead of activation.
Many capable clinical facilities never host trials simply because the start-up burden is too high. Alpha CR Solutions changes that by guiding naive sites through every requirement of their first study.
From building the Investigator Site File to setting up source documents, negotiating vendor contracts and preparing for the site initiation visit, we make sure new sites are genuinely ready, not just nominally activated.
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