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.
• Clinical
• Regulatory
• Quality Assurance and Auditing
• Data Management/Statistics
• Medical Monitoring
• Applying the Australian R&D Tax Incentive when Conducting Research in Australia

Clinical

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 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

REGULATORY

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

Quality Assurance and Auditing

Quality management is an integral part of Molecule2Market’s internal processes, ensuring quality and integrity is built into every aspect of our clinical work. Molecule2Market can also provide dedicated independent Quality Assurance services to our clients to maximize the ethical standards of clinical trials and ensure the highest levels of data integrity. Our experienced QA professionals provide a full range of services for all phases of clinical trials, including:
• investigator site audits
• pharmacovigilance audits
• local central and bioanalytical laboratories
• due diligence
• GLP audits
• systems audits
• phase I units
• trial master file audits
• study documentation review (e.g. protocols, clinical study reports)
• vendor audits (e.g. investigational product management, archive facilities)
• SOP development
• Quality system management

Data Management/Statistics

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)

Medical Monitoring

Molecule2Market can provide Medical Monitoring and Pharmacovigilance Services through Australian-registered medical practitioners.

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.