Managing your studies from initiation to completion.
About Clinical Trial Management
At Accelagen, we pride ourselves on being able to offer the best in clinical trial management from initiation to activation, and execution to completion. Whether you require full or partial study management, our world-leading clinical team can customise trial designs to fulfil your strategic objectives and ensure a successful and seamless development program. Providing expertise across all stages of preclinical and Phase I–IV trials, you can expect the highest quality management in accordance with ICH GCP principles and regulatory requirements. From large multinationals to smaller-scale trials for specialised therapeutics, our team’s primary ambition is to facilitate a successful study that leads to safe and effective treatments that accelerate the landscape of human health and wellness.
Initiation
As part of our initial design process, you will be assigned a dedicated Project Manager who will track and report on progress, timelines and milestones. We also bring in our extensive network of Key Opinion Leaders (KOLs) to help optimise clinical outcomes and fulfil regulatory requirements. Services in this phase include:
Strategic consultation
Regulatory analysis
Medical writing
Site Identification & Feasibility
HREC Planning and Submission
Study StartUp
Biostatistics
Data Management
Study StartUp
Activation
At the Activation stage, we ensure that all essential documentation is reviewed and collected for processing, and that your chosen site has all of the right information, authorisations, site and personnel trained from the outset.
Project Management
Biostatistics
Data Management
Execution
Our Project Managers act as a central point of communication between sponsors, site personnel, participants, physicians and regulators, keeping you informed every step of the way. Our policy is to remain transparent at all times on study status, issues encountered and successes achieved.
Project Management
Site Management
Data Quality Assurance
Clinical Monitoring Management
Safety & Pharmacovigilance
Biostatistics
Data Management
Study StartUp
Study StartUp
Completion
Closing out your study, our team never wavers from our collaborative and patient-centred approach, guiding you down a clear pathway to market that results in meaningful outcomes that improve the future of human health.
Project Management
Medical Writing
Biometrics
Statistical programming
Pharmacokinetics