Contracts must allow for site monitoring and site review now that decentralized trials are a reality. Identify and overcome the challenges of contract language authorizing remote monitoring and assess plans for updating templates for use.
- Ensure consent written in app fits with requirements for subject injury or PHI disclosures and use
- Pinpoint a plan to review records onsite and remotely to fulfill obligations
- Review the need for authorizing remote monitoring
While streamlining CTAs from start to finish may seem straightforward, it can be a complex task. Hear about actionable strategies and useful negotiation tips and tricks to accelerate the CTA process.
- Identify critical timelines for clinical contracting
- Take proactive measures to onboard sites and establish payment procedures efficiently
- Consider the viewpoints of all stakeholders, including sponsors, CROs, and sites, for successful negotiation
Effective communication skills are crucial for enriching stakeholder relationships in clinical trial agreements. Good communication among all stakeholders helps ensure that trials run smoothly and prevents misunderstandings or disagreements. Explore the importance of verbal and non-verbal communication beyond clinical trials.
- Develop communication plans, set clear lines of communication, and define roles and responsibilities
- Discover the key, verbal and non-verbal behaviors that make you more accessible to stakeholders
- Evaluate the necessary elements for communicating a clear, concise, and convincing message
- Recognize communication techniques that can improve your ability to influence stakeholders
Indemnification clauses are the most legally complex passage in any CTA and are notorious for slowing down study startup. These clauses require a complex series of if-then statements – and even a slight error or ambiguity in the text, such as misuse of legal terms or logical glitch, can produce results in court that are radically out of line with parties’ intentions. Review the main legal concepts underlying indemnification and prove a process-focused, field-tested method for breaking down and analyzing indemnification clauses for a quicker, more direct negotiation in a fast-paced environment.
- Learn how to accelerate negotiation time by applying two-part methodology for legal analysis
- Discover industry standard positions of sites and sponsors as to the distribution of liability
- Identify and repair the most common logical glitches in indemnification clauses
For many clinical trial contract specialists, the fine details of the insurance contracts that cover the risks we manage in CTAs are a black box. Insurance coverage is a very specialized field of law where outcomes pivot on extremely precise use of trade usage terms that are unique to that field. This type of tunnel vision creates a risk that a disconnect between language CTAs and an insurance contract could inadvertently put coverage at risk and result in a catastrophic, uninsured loss.
- Identify and navigate the most likely hotspots relating to insurance coverage
- Insurance considerations for both sponsors and sites
Improving coordination between clinical care and research can lead to new approaches to contracting. It is essential to prepare all parties involved in advance for potential difficulties they may encounter.
- Understand the points of view of health systems and clinical centers
- Identify the potential viability problems of the centers
- Overcome obstacles from lack of legal knowledge and the language complexity of research contracts
- Ensure that all stakeholders understand the risk tolerance of the partners
The collection, storage, and use of biological samples in clinical trials are essential for improving medical treatments – and so is ensuring that participants' rights and privacy are protected while using their samples. Discuss the biological sample clauses in Informed Consent Forms (ICFs) and CTAs, and clarify the information provided in ICFs regarding sample storage and how long they will be stored.
- Protect confidentiality and privacy, such as samples labeling, storage, transport
- Determine what issues arise surrounding the use and ownership of biological samples
- Define the potential use for which samples may be used, and provide examples of biomarker analysis, genetic testing, and future research studies using biological samples
IP clauses are getting broader, and you can avoid getting caught up in long-term negotiations that take longer than they should. Although CTAs may struggle with data ownership, this is an area you must always take pains to clarify. Ensure each party understands their responsibilities toward data confidentiality, and clearly stipulates ownership of clinical study results.
- Clarify publication rights and determine the future use of subject data
- Define who can access what data, and minimize the risk of a data breach
- Spell out ownership of samples and whether they can be used for other purposes
International agreements come with their own unique obstacles. Get a better understanding of the important factors to consider when negotiating agreements on a global scale. Compare and contrast clinical trial agreements from various regions such as the EU, Australia, Canada, and Asia-Pacific.
- Analyze the utilization of CROs on a global scale
- Evaluate challenges and strategies for ensuring quality and effective data sharing across continents
- Learn how to maintain compliance standards
Budget may be one of the first things discussed during clinical trial negotiations. Incorporating budgetary guidelines within the agreement on the total amount allotted to the trial, and how this money will be dispersed will set the stage for what is to come.
- Ensure the budget for the testing falls with Fair Market Value (FMV)
- Set terms for the release of funding to the site
- Amend the contract for an expanded budget and why this may be needed
Patient injury provisions are critical components of clinical trial agreements and subcontracts. All stakeholders involved in a clinical trial, including sponsors, sites, and academic medical centers (AMCs), must be prepared to outline their respective provisions in clear and concise language that patients can easily understand.
- Define the patient injury provision in clinical trial agreements and subcontracts
- Discuss the varying positions taken by sponsors, AMCs, and sites
- Highlight the potential impact on the patient
- Identify the challenges associated with different positions
GDPR compliance is a significant undertaking, particularly for specialty pharma and biotech companies with limited resources – and noncompliance can be costly in terms of trial progress and financial penalties. With the increasing complexity of regulations and privacy concerns, it is essential to understand the requirements for collecting, using, and sharing data. This includes identifying data controller and processor, obtaining IC, implementing technical and organizational measures, ensuring subject rights, and implementing data transfer mechanisms.
- Identify rights and integrate transfer mechanisms, including clauses or binding corporate rules
- Address your own GDPR concerns, and identify the timelines and exact compliance issues
- Implement appropriate transfer mechanisms for transferring personal data outside of the EU
The future is now: optimized digital engagement, eConsent, and other methods that aim to put participants first. But, whatever the method used toward informed consent, the goal will always be the same: ensure that patients fully understand the nature of the trial, potential risks, and benefits, and also their rights as participants. Should the participant faces any sort of harm, both sites and sponsor can be held responsible
- Review and reassess the scope of compensation and injury clauses
- Discuss how to ensure participants' protection
- Ensure CTAs contain proper adequate provisions
- Avoid potential major financial penalties