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Clinical Trial

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

Decades of combined industry experience

Regulatory analysis

Identifying gaps and mitigating risks
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Medical writing

Clear and concise brochures and protocols

Site Identification & Feasibility

Utilising our extensive network to get you results
data

HREC Planning and Submission

Charting a pathway to ethics approval and trial success
Regulatory analysis

Study StartUp

Getting you that green light

Biostatistics

Study design and clinical trial protocols

Data Management

Building the infrastructure for seamless activation
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Study StartUp

Getting you that green light

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

Grounded in clear and transparent communication

Biostatistics

Offering various randomisation methodologies

Data Management

Customised solutions tailored to your needs

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 approach is to remain transparent at all times on study status, issues encountered and successes achieved.

Project Management

A dedicated team keeping you informed

Site Management

Close adherence to relevant protocols on site
Quality

Data Quality Assurance

Effective source data verification

Clinical Monitoring Management

On-site and remote source data verification

Safety & Pharmacovigilance

Ensuring participant safety, data integrity and compliance

Biostatistics

Preparation of clear and detailed SAPs

Data Management

Improving efficiency and keeping your data clean
Regulatory analysis

Study StartUp

Getting you that green light
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Study StartUp

Getting you that green light

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

Support to successfully close the project
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Medical Writing

In accordance with ICH guideline E3 requirements
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Biometrics

Presentation and reporting of statistical outputs
Data Management

Statistical programming

Submission-ready CDISC packages

Pharmacokinetics

Improving the benefits for patients

Data Management

Efficient transfer of CRS data

Want to have a tangible impact on the future of human health together?