SOLUTIONS
THE RIGHT SOLUTION, FOR THE RIGHT PURPOSE, AT THE RIGHT TIME.
"Give me six hours to chop down a tree, and I will spend the first four shapening the axe." - Abraham Lincoln
STRATEGY
Developing a clear, concise strategy regarding research & development, clinical studies, reimbursement, and commercialisation can be the key to a successful launch of a new product. At Clinical Evidence Solutions we draw on our prior experience in developing clinical evidence strategies for new products, therapies, claims, and indications to support your business in reaching your goals.
This may include:
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Therapy and device concept development and innovation
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R&D strategy
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IP strategy
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Clinical study strategy
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Regulatory strategy
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Reimbursement strategy
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Commercialisation strategy
PLANNING
A goal without a plan, is just a wish. In order to support you in making your goals a reality, Clinical Evidence Solutions will work closely with you to ensure the planning required is complete and documented.
This may include:
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Clinical study plans
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Key Opinion Leader engagement plans
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Project plans
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Resource and budget requirements
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Grants and other funding applications
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Launch and Marketing plans
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Podium and publication plans
EXECUTION
STUDY MANAGEMENT
At Clinical Evidence Solutions we take an integrated approach to planning and execution of clinical studies, and the post-market opportunities and obigations. We are capable and willing to work with you in a customised manner to suit your companies needs.
This may include:
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Supporting/reviewing ethics submission documentation
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Conducting investigator meetings
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ICH GCP training
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Undertaking study project management, monitoring, etc. to ensure your studies are effective and compliant
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Adverse Event and safety assessments
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Health Risk Assessment
OUTCOMES & COMMUNICATION
RESULTS
Clinical Evidence Solutions are experienced in analysing and interpreting clinical study data to ensure that the outcomes are clearly understood, and accurately presented. This includes specialist biostatistical support if required, and assessing both the statistical and clinical significance of your research.
EVIDENCE DISSEMINATION
We are experienced and willing to work closely with you in the preparation of reports, manuscripts, Board papers, and presentations to facilitate the dissemination and effective communication of your clinical data and evidence.
MARKETING COMMUNICATIONS
All too often researchers and companies underestimate the value and benefit that can come from the focussed and appropriate communication of their research findings. Clinical Evidence Solutions have significant experience in working closely with Marketing Communications specialists to develop and review MarComms material to support the meaningful and compliant communication to your market.
CLINICAL EVALUATION REPORTS (CER)
Regulatory authorities around the world are significantly increasing the focus and rigor required in the Clinical Evaluation Reports (CER) and Post-Market Surveillance Reports - this is particularly true for higher risk classes of devices. Clinical Evidence Solutions has significant experience in the planning and writing of CERs for medical device submissions to many regulatory authorities worldwide.
We can partner with you and your team to support the preparation of your CER, including development of the evidence plan and selection of predicate products for comparison, review of post-market surveillance data, pre-submission meetings with Regulators, literature reviews, and review meetings with Regulators.