Clinical Evidence Gathering

What's your Clinical Story?

In today’s highly competitive health care market, assembling the clinical evidence to ensure an optimal product life cycle for your new drug, biologic, or device must begin years before actual market approval and/or launch. This is especially critical for treatments intended for patients with unmet medical needs, such as rare (orphan) diseases and specialty oncology therapies. In addition, the demands for clinical evidence from the many different health care delivery stakeholders – including physicians, patients, reimbursement agencies, and regulatory authorities – will most certainly change during the long research and development timelines as more information is gathered, interpreted, and acted upon in this constantly-evolving health care environment. With the limited patient populations and an even smaller number of investigators associated with orphan or similar indications, every research participant and every piece of data are critical in building a compelling clinical story to support new drugs and devices.

NovusLife clinical development and medical affairs consultants are dedicated to mapping out the strategies that compile the required clinical evidence from the very beginning of your clinical development programs. In addition to leading clinical research projects from inception through completion – or specific steps in-between – our clinical professionals can help you navigate through challenging research landscapes in which the needs of the many stakeholders must be aligned toward a common destination. We have a depth and breadth of rare disease clinical research experiences and therapeutic expertise to oversee the day-to-day details, yet maintain a focus on the bigger clinical story, to help you quickly identify your program’s critical path, assess possible course corrections over time, track milestones, and facilitate go/no-go decision points.

Specific Services

Targeted clinical evidence seminars (complimentary)
Clinical evidence strategy development
Program management
Study design and management
Stakeholder alignment and team building
Site selection and relationship management
Publication planning

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