Phase IIb Studies: Assessing Efficacy and Optimising Dosing in Clinical Trials

Phase IIb Studies: Assessing Efficacy and Optimising Dosing in Clinical Trials

As a leading Australian CRO, Datapharm Australia specialises in managing Phase IIb clinical trials, a critical stage in drug development focused on assessing efficacy,

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SAD and MAD Studies in Early Phase Clinical Trials: Ensuring Drug Safety and Efficacy

SAD and MAD Studies in Early Phase Clinical Trials: Ensuring Drug Safety and Efficacy

As a leading Australian CRO, Datapharm Australia specialises in the critical early stages of clinical development, including Single Ascending Dose (SAD) and Multiple

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Clinical Monitoring in Early Phase Clinical Trials: Ensuring Data Integrity and Patient Safety

Clinical Monitoring in Early Phase Clinical Trials: Ensuring Data Integrity and Patient Safety

Early-phase clinical trials, encompassing Phase I and Phase IIa studies, are critical steps in the drug development process. These trials aim to evaluate the safety,

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Australia's Original Full Service CRO

Datapharm has earned an enviable reputation for detail and quality through involvement in hundreds of clinical trials in all phases (Phase I to IV) for clients ranging from large international pharmaceutical companies to local and international biotechnology companies, device manufacturers, producers of alternative therapies, private, hospital and university based investigators.

Clinical Trial Services

Datapharm is Australia’s original full service contract research organisation (CRO) providing clinical trial services such as Clinical Trial Site Selection, Regulatory and Site Set-up, Clinical Trial Monitoring Services, Data Management, Statistics, Medical and Scientific Writing, Medical Monitoring and Pharmacovigilance, Quality Control Processes and GCP Auditing.

Clinical Research Therapeutic Expertise

With over 35 years of experience, Datapharm has proudly managed clinical research across all phases and most therapeutic areas for both early phase clinical trials and late phase studies.
Datapharm has relationships with some of the best clinical trial Investigators and study sites in Australia and New Zealand. Read more about Datapharm’s clinical trial therapeutic area experience.

Clinical Trial Management Speciality

Our clinical trial Sponsors’ budgets are managed using Project Advantage® and Project Status Invoicing which present project phases by work category against estimated and actual time and cost. As part of our service to you our project managers will work with timelines for data analysis to meet prearranged presentations to client boards or funding agencies. Datapharm Australia CRO clinical trial management services include clinical trial design, preparation of all necessary clinical trial documents, clinical site monitoring, data management, statistical services and medical monitoring and pharmacovigilance.

Testimonials

Thank you so much for your hard work in achieving this milestone! We really appreciated your responsiveness, flexibility and professionalism throughout this trial. Fabulous work!!
Australian biotech company
I want to thank you and the team at Datapharm for all the effort in putting together the data to date from our trial. We have been working to very tight timelines, and I know that this has not been ideal for any one. Your team’s professionalism has been fantastic, and everyone here really is very appreciative. I know that it can be problematic dealing with sites in other countries, which adds an extra level of challenges. Please pass on my thanks to everyone.
Australian Biotechnology Company
I’ve just attended a two day course in Brisbane as an Introduction to Clinical Research. I’m just writing a quick note to thank your company and the presenter, Eleanor Allan. I have only been involved as a study coordinator for the last 7 months, without any official training. The course has helped consolidate and expand on my self-taught knowledge, and has left me with a determination to further improve the Clinical Trials unit here at my Hospital. Eleanor was an amazing presenter, listening to our own stories and sharing her own, to develop a shared meaning. Her knowledge of GCP and Ethics was simply exemplary. Once again, thank you. Please pass on my gratitude to Eleanor.
Study Coordinator, Queensland
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