Agreements that are Required for Clinical Trials

AstraCrux assists pharmaceutical & biotechnology companies and CRO clients by drafting and negotiating clinical trial agreements, as well as finding prompt solutions to other contractual obstacles involved in running clinical projects and conducting research. 


Our contract specialists have science and law background and are among the most experienced in the Asia-Pacific region. In some cases, they have managed the delivery of over 1,000 Clinical Site Agreements (CSAs) per year while working for some of the world’s biggest CROs.


Please refer to the diagram below which summaries the typical CSA process during the clinical trial start-up phase.


Flow diagram.jpg


The diagram is for illustrative purposes only. We pride ourselves on a highly flexible approach and can adjust our negotiation strategies to suit the client’s needs and goals.


Below is a summary of the services we offer.


Negotiating and drafting Clinical Site Agreements (CSAs)

Our contract specialists can assist in reducing timelines in the critical start-up phase by:

  • Applying their knowledge of the clinical trial industry and local business practices when negotiating CSAs and auxiliary contracts 

  • On behalf of Sponsor/CRO, negotiating contracts with institutions directly, thus removing communication delays 

  • Conducting all communication and negotiations in both English and local languages


Budget negotiations for Clinical Site Agreements (CSAs)

AstraCrux staff also have extensive experience negotiating clinical trial budgets. Our negotiators can:

  • Together with the client, determine appropriate investigator site fees for each country participating in the study

  • Implement strategies that are tailored to take into account any country-specific factors as well as the bargaining power of each party 

  • Adjust their style and approach according to the negotiation styles employed by the parties


Drafting, Negotiating and Reviewing Related Agreements

Below is a list of agreements we can assist with, either as part of the CSA process or on stand-alone terms:

  • Master Service Agreements (MSA) 

  • Confidentiality Disclosure Agreements (CDA) 

  • Letter of Indemnity (LOI) 

  • Key Opinion Leader Agreements (KOLA) 

  • IP Transfer Agreements 

  • Licensing Agreements 

  • Contractor/Consulting/Services Agreement 

  • Material Transfer Agreement (MTA) 

  • Data Use Agreements (DUAs)

 

Other Related Services

  • In addition to the services described above, we can offer you complete legal coverage through our international alliance network with local law firms. Please contact us for further information.