Strategy
GLIAL consultants have decades of clinical and therapeutic experience in effectively managing hundreds of trials, programs and company portfolios, and we intimately understand what it takes to navigate the complexities of the ever changing, or dynamic clinical landscape.
GAP Analysis
In the high-stakes world of drug development, where corporate goals, budgets, investor expectations, and the well-being of patients and their families are on the line, starting on the right track is crucial.
Conducting a Gap Analysis helps identify potential risks, enabling teams to devise plans for risk minimization and management. This comprehensive assessment covers the following key areas:
Therapeutic Landscape
Analyze the current market and competition to ensure your product is positioned optimally.
Clinical Trial Landscape
Evaluate the design and feasibility of your clinical trials to maximize efficiency and success.
Cost- Budget Analysis
Review the financial aspects of the project to ensure optimal resource allocation and cost control.
Regulatory Landscape
Examine the legal and regulatory requirements relevant to your product's development and approval.
Risk Assessment and Management
Identify, assess, and manage risks throughout the project lifecycle to minimize potential setbacks.
By performing a Gap Analysis, your team can proactively address challenges, making it less likely to encounter costly setbacks or require a complete change in direction.
“I had the pleasure of working with Kim at KeifeRx, where she was Vice President/Head of Clinical Operations. Kim is a talented, “roll your sleeves up”, clinical development executive. Kim’s understanding of global clinical research, regulatory compliance, and quality assurance across the compound’s lifecycle enabled her to assess and mitigate risk against potential development issues impacting study performance and regulatory approval. Kim quickly translated clinical and study financial demands into partnership realizations while sustaining quality and maintaining business continuity. She has an effectual ability to communicate value propositions that resonate with key stake holders, regulatory authorities, key opinion leaders and partners. An executive professional with integrity, research, and development expertise, who unceasingly drives a quality culture.”
Chris Hoyt
Chief Executive Officer | KeifeRx
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