AK CLINICAL RESEARCH

The clinical research management and monitoring specialists in Australia and New Zealand

Our Mission

Our mission is to assist our clients in successfully completing their clinical trials by providing effective clinical research services, leveraging extensive and diverse expertise from industry and academia.

 

We are an Australian Clinical Research Organisation that provides high quality Clinical Project Management, Clinical Trial Monitoring and Medical Writing services for early phase clinical trials, with over 15 years of experience in clinical trials, working for global pharmaceutical companies and CROs in Europe and Australia, and over 20 years of writing experience in industry and academia.

Our Services

Clinical Project Management

Expertise from start to finish

Our Clinical Project Managers and consultants are reliable and professional with a proven track record for quality service and come with a positive attitude of putting clients first. Our consultants have extensive experience working for pharmaceutical companies and CRO’s. They value the importance of working with client’s deadlines and budget while being proactive when the need arises.

Clinical Trial Monitoring

Phase I-IV clinical trial expertise

Our Clinical Trial Monitors are reliable and professional with a proven track record for quality service and come with a positive attitude of putting clients first. Our CRAs have extensive experience working for pharmaceutical companies and CRO’s. They value the importance of working with client’s deadlines and budget while being proactive when the need arises.

Medical Writing

Accurate, compliant, submission-ready documents

At AK Clinical Research, we leverage our 15 years of experience in clinical trials, and over 20 years of writing experience in industry and academia to effectively deliver a wide range of medical writing services. We will actively engage with the sponsor and generate a multitude of important documents, from protocol synopsis to final clinical study report.

Site Setup and GCP training

Good Clinical Practice Training

The GCP training is CPD certified and meets the minimum criteria for Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. The GCP training materials are developed and owned by Sophie Mepham GCP©, protected by copyright and licenced to AK Clinical Research.

Clinical Research Site Services

A private site with expedited regulatory and set up processes.

At AK Clinical Research we are experienced in delivering phase II-IV interventional studies. We have partnered with an extensive network of highly trained and experienced investigators in general practice to facilitate faster trial recruitment.

A range of clinical trial solutions
We understand that CRO services need to be modular and adhere to the highest standards of quality and regulatory compliance. We have established a broad and integrated network of vendors allowing for efficient clinical trial conduct. We partner with Sponsors, traditional and virtual research sites, to create and deploy clinical trial solutions that are highly customized and unique to each situation.

We deliver the following services:

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Clinical protocol development

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Preparation of regulatory submissions

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Site Setup and GCP training

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Investigator site staff training

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Study monitoring and project management