A Clinical Trial Agreement defines the conduct of research between a sponsor and study site. This playbook emphasizes regulatory compliance, data ownership, and subject safety responsibilities.
Why This Matters: Robust dispute procedures reduce resolution time, control legal costs, and maintain business relationships.
Negotiation strategy
If you're the Sponsor:
Ensure the dispute resolution clause aligns with company policy, including preferred forums and governing law. Propose edits if the current clause does not meet these standards.
If you're the Institution:
Negotiate for a dispute resolution process that is efficient and cost-effective. Consider the implications of the chosen forum and governing law on enforceability.
Essential elements
1
Forum Selection
Preferred location for resolution.
2
Governing Law
Jurisdiction applicable to disputes.
3
Resolution Timeline
Timeframe for resolving disputes.
Action framework
ACCEPT
Propose edits if the forum or governing law is not preferred. Ensure timelines are clearly defined.
EDIT
Reject clauses that do not allow for efficient resolution or align with company policy.
ADD
Add a robust dispute resolution clause if missing to protect interests.
PRO TIP
Always ensure the dispute resolution mechanism is consistent with past agreements and company policy.
Example clauses
FAVORABLE
Preferred Clause
"Any dispute arising out of or in connection with this agreement shall be resolved by arbitration in New York under the rules of the American Arbitration Association."
NEUTRAL
Fallback Clause
"In the absence of agreement, disputes shall be resolved by mediation followed by arbitration under ICC Rules, with the seat of arbitration in a mutually agreed location."
UNFAVORABLE
Non-Preferred Jurisdiction
"Disputes shall be resolved under the laws of a non-preferred jurisdiction, which may increase costs and complexity."
Fallbacks
High-Risk Projects
In high-risk projects, ensure the dispute resolution process is expedited to minimize potential disruptions.
International Contracts
For international contracts, consider arbitration in a neutral location to avoid jurisdictional biases.
Long-Term Agreements
In long-term agreements, ensure the dispute resolution mechanism is flexible to adapt to changing circumstances.
FEATURED SOLUTIONS
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WEEK 1
CLM Readiness and Design
Our CX team works with you to understand your contracting challenges, prioritize key workflows, and identify the biggest impact areas. We build a tailored implementation plan that fits your needs.
WEEK 2
Install Module
We connect DocJuris to your contract repositories, set up admin and user accounts, and ensure your environment is ready for success.
WEEK 3
Deliver & Test
Your team builds initial playbooks, reviews existing clause libraries, and trains the DocJuris agent to align with your internal standards and negotiation positions.
WEEK 4
Launch
We support you in rolling out DocJuris to a pilot group or your full organization—with launch materials, training, and hands-on support to drive adoption from day one.
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DocJuris is not a law firm or a substitute for an attorney or law firm. We cannot provide any kind of advice, explanation, opinion, or recommendation about possible legal rights, remedies, defenses, options,selection of forms or strategies.