Our Services
At MAJOR Research, we provide comprehensive consulting and support services designed to ensure the success of your clinical trial. With a wealth of experience across the pharmaceutical, device, medtech, and biotech sectors, we offer tailored solutions that meet the unique needs of each research project. With experience across the breadth of trial design, implementation, and delivery, MAJOR Research brings deep industry knowledge and innovative approaches to every phase of clinical research. We understand the complexities and challenges inherent in clinical trials and are committed to delivering high-quality, efficient, and participant-centric solutions. Whether your trial is traditional, hybrid, or fully decentralised, MAJOR Research is dedicated to helping you navigate the landscape of clinical research with confidence and precision.
Strategic Consulting
Our strategic consulting services are designed to guide you through every phase of your clinical trial. We offer:
- Protocol Optimisation: Review and recommendations for amendments to any current protocol or study summary, providing both plain language and technical explanations of any digital inclusions in your study activities.
- Study Workflow Designs: Visual mapping of the possible pathways and events of your study, detailing each participant's potential journey. These tools support your regulatory submissions, study team and site team training, participant informed consent and education, and resource planning, particularly in decentralised or hub-and-spoke style models such as Teletrials.
Hybrid and Decentralised Trials
Specialising in hybrid (Teletrials) and decentralised clinical trials, we offer:
- Decentralised Trial Design: Custom designs that bring the trial to the participant, reducing travel and time commitments.
- Recommendation, Evaluation, and Vendor Management of Decentralised Solutions: Identifying suitable and compliant options for delivering your study, including software, hardware, direct-to-participant delivery, remote monitoring, and data capture.
- Participant Engagement: Tools and strategies to maintain high levels of participant engagement and satisfaction from recruitment to the end of follow-up periods and open-label extensions.
Patient-Centric Approach
Our commitment to a patient-centric approach ensures that your trials are designed with participants in mind:
- Participant Education: Informative materials and resources to educate participants about the trial and their role, provided in multiple ways that support diverse learning and comprehension styles and requirements.
- Feedback Mechanisms: Systems to gather and act on participant feedback to improve the trial experience or to engage with consumer representatives for preemptive review of trial ideas.
Diversity, Inclusion, and Equity
Through lived experience and active engagement with populations frequently underrepresented in clinical trials, we offer:
- Inclusive Language Review: Protocol, consent form, and data capture review to identify wording that unnecessarily excludes participants, doesn’t allow for accurate responses, or presents safety concerns where assumptions or binaries restrict access to information or testing procedures.
- Access Reviews: Review of participant workflows or trial activities to identify areas that may be barriers to participation for culturally or linguistically diverse populations, vulnerable populations, and where accessibility requirements can be provided.
Training and Support
Comprehensive yet engaging training can reduce risk and compliance issues in your study. Delivered in a culturally competent and learning style adaptive manner, we offer:
- Customised Training Programs: On clinical trial processes, governance, and regulatory requirements; digital health systems being utilised in a study; study-specific training materials; and participant education.
Australian R&D Tax Incentive
We help clients navigate funding opportunities to maximise the value of their research investment, including:
- R&D Tax Incentive Applications: End-to-end support for preparing and lodging advanced and standard findings applications under the Australian R&D Tax Incentive scheme.
- Overseas Finding Assessments: Eligibility review and advisory for research activities conducted outside Australia, ensuring your offshore work is appropriately captured and compliant.
- Onshore Resource Facilitation: Identifying and connecting you with Australian-based facilities, CROs, and specialist providers to support bringing your research program to Australia.