The purpose of a Contract is to detail and formalise the agreement between parties. Early planning of the contractual structure, format, process is as important as the Terms & Conditions if study activities are to be completed on schedule.
Integrating the negotiating positions of the Sponsor's Legal Counsel requires understanding of provider perspective so that compromise and agreement can be reached quickly and fairly for all parties. This can be actively supported by OM360.
Protection of Commercially Sensitive information works both ways
Although it may appear less onerous to push for a unilateral CDA, it limits early dialogue and, should the relationship progress to MSA will be superseded by a bilateral agreement anyway. Most CROs will be flexible at this stage but they are mindful that pricing information is one of their most sensitive areas.
Start-Up Agreement (SUA) vs. Letter of Intent (LOI)
The US Sarbanes-Oxley Act enforces a good business principle of a Third Party not commencing work without a formal Agreement in place. LOIs used to come in many shapes and sizes but were open to misuse without basic contractual terms included. A good SUA can essentially be a LOI that agrees basic Terms & Conditions and describes work that can be invoiced and ultimately reconciled. However, it has limitations of use that need careful management.
Master Service Agreement (MSA) or Service Agreement?
Selection of the right format of Agreement needs deciding very early in the process. As with any Legal document, it may take considerable time to finalise. Therefore chosing the right type and scope (Global or Regional?) from the start is important - as is having strong, clear and fair business terms to manage potential delay, cancellation or termination scenarios.
Work Orders should be adaptable to project specifics.
Whilst a Work Order shouldn't duplicate the MSA and carry minimal legal Terms & Conditions, it may need terms and details to cover individual project scenarios such as performance and accountability. This goes alongside the distinct appendices required to contract the provider.
Don't wait for a Change Order to be presented
Study changes are almost inevitable as the scale of a project increases. OM360 can apply knowledge gained from sometimes painful experiences of managing change of scope and cost. From linking issue tracking to reconciliation of SUWO and final study costs, the process needs to be clear and transparent from the very beginning to all parties involved if dispute and delay is to be avoided.