Contracts Associates
Contracts Associates is a law firm specializing in life sciences and pharmaceutical contracts. With over 13 years of experience, their agile team of attorneys provides industry-specific legal services, including drafting, negotiating, and finalizing clinical trial agreements, research and development contracts, and supply and distribution agreements. They support clients across the entire drug development process, from research to post-market studies, ensuring contracts are meticulously drafted and aligned with regulatory requirements. Their mission is to help pharmaceutical and biotech companies meet deadlines, mitigate risks, and build strong relationships through fair and equitable contract terms.
Industries
Nr. of Employees
small (1-50)
Contracts Associates
Boston, Massachusetts, United States, North America
Services
Project-based drafting and negotiation of clinical trial agreements, CRO agreements, informed consent documents, and related trial contracts.
Rapid intervention to resolve stalled contract negotiations and support study start-up timelines with experienced negotiators.
Creation of customized agreement templates and contract review workflows to standardize terms and speed future negotiations.
Drafting data processing and data representative terms for GDPR compliance and advising on cross-border clinical data transfers and Brexit-related impacts.
Performing cyber gap analyses and drafting insurer- and regulator-facing contract clauses to address cloud, remote-work, and ransomware risks.
Project-based drafting and negotiation of clinical trial agreements, CRO agreements, informed consent documents, and related trial contracts.
Rapid intervention to resolve stalled contract negotiations and support study start-up timelines with experienced negotiators.
Creation of customized agreement templates and contract review workflows to standardize terms and speed future negotiations.
Drafting data processing and data representative terms for GDPR compliance and advising on cross-border clinical data transfers and Brexit-related impacts.
Performing cyber gap analyses and drafting insurer- and regulator-facing contract clauses to address cloud, remote-work, and ransomware risks.
Expertise Areas
- Clinical trial contracting
- Regulatory compliance for clinical research (GDPR, HIPAA, IRB)
- Sponsored research and material transfer agreements
- Supply chain and manufacturing agreements
Key Technologies
- Contract lifecycle management systems
- Cloud-based data storage and transfer
- GDPR compliance frameworks
- HIPAA privacy and security frameworks
News & Updates
Contracts Associates will attend the Cyber Security Summit to enhance expertise in cyber risk mitigation, focusing on remote work, cloud computing, and ransomware threats.
Discussion of proposed deregulations by HHS/FDA, including IRB approval process and informed consent regulations.
The draft 2020 ICH(E8)R1 guideline is open for sponsor comment, focusing on study design, patient input, investigator input, and operational criteria.
Discussion on data transfer issues post-Brexit, including GDPR considerations and UK data protection laws.
Support for sponsors in contract negotiations and reviews to meet clinical trial milestones, especially when resources are limited.
Massachusetts law now regulates non-compete agreements, affecting employment contracts and enforceability.
Contracts Associates will attend the Cyber Security Summit to enhance expertise in cyber risk mitigation, focusing on remote work, cloud computing, and ransomware threats.
Discussion of proposed deregulations by HHS/FDA, including IRB approval process and informed consent regulations.
The draft 2020 ICH(E8)R1 guideline is open for sponsor comment, focusing on study design, patient input, investigator input, and operational criteria.
Discussion on data transfer issues post-Brexit, including GDPR considerations and UK data protection laws.
Support for sponsors in contract negotiations and reviews to meet clinical trial milestones, especially when resources are limited.
Massachusetts law now regulates non-compete agreements, affecting employment contracts and enforceability.