My Services

From pre-clinical through to global late-phase clinical development, including:

• Bespoke Collaboration and R&D Agreement drafting and negotiations with IP focus, both academic and commercial, including ancillaries such as Material Transfer Agreements; 
• ­Global clinical trial and ancillary agreement template suites (including fallbacks), negotiations and dissemination; 
• ­Outsourcing/Vendor Management covering RFPs, CRO Master Service Agreement development and negotiations and ancillaries; and 
• ­Collaborative development projects (inc. NHS) of Apps and SaaS platforms.

Practical global compliance advice and support, including:  

• ­Review and updates of existing compliance programmes of clients who have licensed products in the UK and EU markets;
• Development and implementation of compliance programmes for clients who are launching and/or have recently launched licensed products in the UK and EU markets, including training; 
• ­IFPMA, EFPIA and National Code Compliance regulatory advice, workflows, contractual template suites and contractual support covering permitted Healthcare Recipient interactions and annual transparency reporting; 
• ­Deep dives into legacy compliance practices and corrective actions;
• Transparency and market value assessment advice and reporting architecture utilising SharePoint; and 
• Anti-bribery & corruption and due diligence advice and risk-based solutions.

General and life-sciences specific data privacy advice and transactional support, including:

• ­Deep dives into legacy practices and corrective actions (through to implementation and training);
• Creation of global data privacy programmes, including mapping, policies, ROPA, data processing activity assessments (lawful basis, LIA, DPIA, TRA etc) and Data Processing Agreements (drafting, evaluation and negotiations).
• Clinical Trial Data Protection specific documents, including Patient Information Sheet / Informed Consent and Protocol language.

Wide scope of set-up and transactional support, spanning manufacturing and supply, product development services (with IP focus), distribution and licensing (in and out), including:

• ­Development of bespoke agreement templates for global use;
• Evaluation and negotiation of individual agreements; and
• Practical Health & Safety & Environmental matters including investigations.

Design and set up of self-service legal portal structures and contract management systems in SharePoint, particularly valuable for companies with small (or no) in-house legal teams (and smaller budgets) to enable non-legal personnel to generate high-volume agreements in a secure and monitored environment using templates, accessing understandable guidance and requesting legal support as required. 

Examples include:

• Ancillary Services Agreements (eg Laboratory, Pharmacy, Radiology);
• Confidentiality Agreements;
• Consultancy Agreements (general and HCP);
• Employment Agreements;
• In & Out Licensing Agreements;
• Intercompany Agreements;
• Master Services Agreements;
• Material Transfer Agreements;
• Pharmacovigilance Agreements;
• Quality Agreements; and
• SaaS Agreements.