Our Practice Areas
Clinical Research
In the intricate landscape of clinical research, where clinical research sites engage in intricate agreements with powerful pharmaceutical and medical device giants, the paramount objective of Ser & Associates is to safeguard the rights and interests of our clients, the clinical research sites.
In a scenario often reminiscent of David-and-Goliath dynamics, clinical research sites stand in need of expert legal counsel, equipped with the experience to skillfully shield the interests and effectively mitigate potential risks of the clinical research sites.
Drawing upon over a decade’s worth of experience in the field of clinical research, Ser & Associates takes on the role of an invaluable partner, providing tailored legal guidance that resonates with the unique challenges posed by contractual intricacies, regulatory compliance, and complex operations.
Clinical trial agreements (CTAs)
Clinical trial agreements (CTAs) assumes are the core document for clinical research. CTAs govern the relationship between the pharmaceutical/medical device companies and the clinical research sites.
Ser & Associates understands the nuanced power dynamics at play in these agreements, and the corresponding negotiations.
Our legal team navigates the intricacies of CTAs with thorough attention, ensuring that the interests of clinical research sites are thoroughly protected. Through negotiation, we seek to ensure the CTAs address critical matters important to clinical research sites, such as, payment terms, subject injury, and indemnification, in manner that fair and equitable for the clinical research sites.
Consent forms (ICFs)
At the core of the regulations governing clinical research lies the objective of safeguarding the rights and welfare of participants.
A quintessential component of this are informed consent forms (ICFs) with provide regulatory required disclosures to possible participants so they can make an informed decision on whether to participate in the clinical research. We review the ICFs on behalf of the clinical research sites to ensure strict alignment with the regulatory requirements.
Clinical research sites often utilize service providers to deliver critical assistance necessary for clinical research. Ser & Associates also assists in drafting and negotiating service provider agreements. This includes drafting and negotiating agreements with various doctors to provide the role of principal investigator to the clinical research site.
The complex breadth of clinical research calls for legal guidance that goes beyond the ordinary.
Ser & Associates, with its commitment and proven decade-long track record, navigates clinical trial agreements, regulatory compliance, and operational considerations to maximize our clients’ protection.
Through a seamless blend of legal acumen and industry insight, our firm empowers clinical research sites to navigate their endeavors with a sense of confidence. With each step, we fervently seek to protect our clients’ interests in their endeavor to advance the noble cause of scientific discovery and innovation.