Sponsor teams are always under pressure to pause, pivot, and accelerate clinical programs based on a wide range of external factors. Efficient and effective clinical programs require having all of the functional players ready on "go". While building internal expertise provides long-term advantages, having access to a diverse community of consultants levels-up a team's ability to respond to all of the program dynamics.
The Value of External Expertise
One of the primary benefits of leveraging external expertise is the access to highly specialized skills that may not be readily available internally. Whether it is rare conditions, novel TA approach, or tech-specific requirements, collaborating with external professionals can help ensure programs and submissions meet requirements while maintaining timelines.
The only certainty is uncertainty in clinical programs. Teams can gain flexibility and adapt to changes when safety boards, patients/sites, internal personnel, regulators, or senior management calls an audible at the line of scrimmage. Specific advantages include:
Budget Management - demand-based consultant partnerships reduces fixed liabilities related to large internal teams.
Timeline Management - core team agility through consultant partnerships ensures optimal resource allocation to address project priorities and timelines. This scalability is particularly useful for companies dealing with reduced pipelines or fluctuating project requirements.
Challenges Related to External Partnerships
While consultant engagement offers a number advantages, it isn't all blue skies and butterflies. Common issues can be avoided with careful planning and best practices, including:
Timeline Assurance - unfettered communication is requisite for complete alignment. Crossed-wires can lead to delays and errors, but clear objectives and priorities along with regular meetings will help avoid pitfalls.
Budget Assurance - an over-dependence on external vendors can cause over-runs if not carefully managed. Prioritizing vendor selection based on proven expertise and reliability. Good vendors can help negotiate robust contracts, and establish performance metrics to maintain control over project outcomes.
Why Independent Consultants Are an Ideal Solution
Contract Research Organizations (CROs) can solve most challenges for sponsor teams but struggle with small-scale needs resolution. Independent clinical research consultants offer more flexibility, along with a specialized expertise and person access. Their adaptability fosters closer collaboration with internal teams, resulting in more seamless integration and better outcomes.
Independent consultants offer tailored pricing - pay for what you need, and nothing you don't.
The personalized, adaptable, and cost-effective approach that consultants bring to clinical programs allows program teams more precision when they must carefully address complex needs and timelines.
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