Attorney at Law
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Lisa A. Mammel
I provide legal counsel to clients who are developing pharmaceutical and medical device products for regulatory approval in the U.S. and abroad. My expertise comes to bear at all stages of the development process, including: early innovation; testing and development; U.S. and foreign-based clinical trials; regulatory approval; and marketing. Among the services I routinely provide are those found in the following areas:
Clinical Trial Agreements
* Draft specialized Clinical Trial Agreements for Sponsor’s use with U.S. and foreign sites (including sites located at academic institutions and those in physician practices)
* Draft customized Clinical Trial Agreement templates for administration and use by Sponsor or C.R.O.
* Negotiate Clinical Trial Agreements (including negotiation in several languages)
* Draft and negotiate Investigator Supported Trial Agreements (ISTs)
* Advise on clinical trial regulatory compliance issues
* Advise on transparency and accountability compliance
Informed Consent Documents and Trial Recruitment Documents
* Draft and edit Informed Consent Forms
* Interact with IRBs so as to assure compliance with IRB rules
* Advise on use of media for recruitment of clinical trial subjects
* Advise on authorization documents with regard to PHI
Foreign Clinical Trial Matters
* Draft Power of Attorney documents for foreign–based clinical trials
* Provide legal counsel on foreign data privacy issues, including GDPR compliance
* Draft country-specific Clinical Trial Agreement templates
* Negotiate with foreign clinical trial sites and liaise with foreign-based CRAs
Contract Research Organizations
* Draft and negotiate Contract Research Organization Agreements
* Draft and negotiate Master Services Agreements
* Interact with CROs to increase clinical trial efficiency
Additional Documents
* Draft and negotiate Non-Disclosure Agreements
* Draft and negotiate Manufacturing and supply, Material Transfer and Laboratory Agreements
* Draft and negotiate Consulting Agreements and Scientific Advisory Board Agreements
Clinical Trial Agreements
* Draft specialized Clinical Trial Agreements for Sponsor’s use with U.S. and foreign sites (including sites located at academic institutions and those in physician practices)
* Draft customized Clinical Trial Agreement templates for administration and use by Sponsor or C.R.O.
* Negotiate Clinical Trial Agreements (including negotiation in several languages)
* Draft and negotiate Investigator Supported Trial Agreements (ISTs)
* Advise on clinical trial regulatory compliance issues
* Advise on transparency and accountability compliance
Informed Consent Documents and Trial Recruitment Documents
* Draft and edit Informed Consent Forms
* Interact with IRBs so as to assure compliance with IRB rules
* Advise on use of media for recruitment of clinical trial subjects
* Advise on authorization documents with regard to PHI
Foreign Clinical Trial Matters
* Draft Power of Attorney documents for foreign–based clinical trials
* Provide legal counsel on foreign data privacy issues, including GDPR compliance
* Draft country-specific Clinical Trial Agreement templates
* Negotiate with foreign clinical trial sites and liaise with foreign-based CRAs
Contract Research Organizations
* Draft and negotiate Contract Research Organization Agreements
* Draft and negotiate Master Services Agreements
* Interact with CROs to increase clinical trial efficiency
Additional Documents
* Draft and negotiate Non-Disclosure Agreements
* Draft and negotiate Manufacturing and supply, Material Transfer and Laboratory Agreements
* Draft and negotiate Consulting Agreements and Scientific Advisory Board Agreements
Services