Services

Molecule2Market offers our clients the simplicity of support through one organisation. We provide services across a range of disciplines involved in pharmaceutical and device research, development and commercialisation in a highly flexible manner to meet customer needs.

Molecule2Market provides proven expertise in managing projects across all phases of pharmaceutical R&D, and in optimising the performance of a portfolio, both in terms of strategic decision making and operational management of resources.
Our team of talented and experienced researchers is available to carry out defined work packages across the USA and Asia Pacific region including:

project feasibility
site selection
study start-up (including ethics submissions and contract negotiation)
monitoring
project management
patient recruitment
local safety reporting
quality management (quality review and audit preparation, inspection readiness audits)
site close out

All clinical trials conducted in Australia must have a trial sponsor that is an Australian entity (an overseas company cannot be the sponsor of a trial in Australia).

The Australian trial sponsor carries the medico-legal responsibility associated with its conduct and is also the entity responsible for submitting a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA). There are two options for the Australian trial sponsor:

If the overseas company does not have an Australian entity, M2M can act as the Australian Sponsor.
If the overseas company is interested in leveraging the Australian Research and Development (R&D) Tax Incentive, an Australian subsidiary will need to be created. The subsidiary will require a Resident Director, which M2M can provide. As Resident Director, M2M can recommend a R&D tax specialist.

The team at Molecule2Market can oversee the regulatory requirements of pharmaceutical and medical device products in the USA and Asia Pacific Region.

With significant expertise in the registration and maintenance of medicines and medical devices, we support our clients to achieve their objectives in an efficient and cost-effective manner.

We have experience across most therapeutic areas, and can manage all size regulatory projects, from minor variations to the submission of new biotech products.

Molecule2Market offers our partners the simplicity of support through one organisation, whilst maximising the data obtained to support the regulatory or clinical development strategy.

An experienced Medical Writer can assist with the development of regulatory documents for clinical trials including but not limited to:

Study Protocols and Amendments
Investigator's Brochures and updates
Clinical Study Reports
Abbreviated Clinical Study Reports
Interim Safety Reports
Patient Information Sheets and Consent Forms

All documents are prepared in line with the latest regulatory guidelines and are presented in a clear and succinct format.

Medical Writers at Molecule2Market have extensive experience in development of regulatory documents for dedicated Phase 1 study sites in Australia for approval by Australian ethics committees.

Our Medical Writers work closely with clients, project managers, investigators, study coordinators, data management groups and biostatisticians to produce high quality documents in a timely cost-effective manner.

Quality Management

Quality management is an integral part of Molecule2Market’s internal processes, ensuring quality and integrity is built into every aspect of our operations. Our internal Quality Management System has been independently audited. Our QA professionals can assist clients with SOP development and implementation of a robust Quality Management System. Regular QC is conducted on all projects to ensure compliance and to look for opportunities for process improvements.

Auditing

The Molecule2Market auditing team can provide a full range of services for all phases of clinical trials, including:

investigator site audits
CRO audits
pharmacovigilance audits
GLP audits
systems audits
trial master file audits
EC/IRB audits
vendor audits (e.g. investigational product management, archive facilities)
mock regulatory agency audits

Our auditors are highly professional and bring significant industry experience and expertise. They will identify gaps in current practices and work collaboratively to identify recommendations for addressing these, including prioritisation of findings. Our audit team works independently from our clinical operations team.

Our data management group provide high quality, cost effective solutions to ensure your clinical trial data is delivered successfully.

protocol development/review
eCRF/CRF design, review and print management
analysis plan support – meeting support and representation
EDC vendor review and/or user acceptance testing
technical document preparation and review
site and monitor study specific training
data safety monitoring – assistance with setup and coordination
biostatistical support (local or FDA experts)

Molecule2Market can provide Medical Monitoring and Pharmacovigilance Services.

The function of the Medical Monitor will be determined to meet our client’s needs and can include:

response to site questions about subject eligibility or other safety or medical issues arising at commencement or during the course of a clinical trial
participation in DSMB meetings to discuss safety issues arising during a clinical trial
review of safety information and responding to any questions raised by members of the team
review of all SAEs for relationship to study medication and expectedness according to IB or product information
writing safety narratives and following up until resolution of an event
review of all adverse events in the clinical database at regular intervals, and reporting any safety issues/trends to the sponsor and the DSMB chair

Conducting research in Australia

Did you know you the R&D Tax Incentive program is the Australian Government’s principle measure to enhance and increase the amount of research and development undertaken by Australian businesses?

The R&D Tax Incentive provides eligible entities with a tax offset for expenditure on eligible R&D activities and for the decline in value of depreciating assets used for eligible R&D activities.

The R&D Tax Incentive replaced the previous R&D Tax Concession for income years commencing on or after 1 July 2011.

The objectives of the R&D Tax Incentive program are to provide a tax offset to make eligible companies more competitive and improve productivity across the Australian economy by:

encouraging industry to conduct R&D that may not otherwise have been conducted
providing business with more predictable, less complex support
improving the incentive for smaller firms to engage in R&D

Molecule2Market can provide you with a local R&D tax expert who can walk you through the requirements to qualify for these incentives, and help you every step of the way.

Lets have a chat about your project.

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