Our client is a global pharmaceutical company with almost 30 affiliates around the world. Keen to set up a clinical oversight system, they have taken a decision to introduce a technology solution to conduct oversight in highly efficient and compliant way.
The clinical oversight solution had to be compliant with the ICH GCP E6 (R2) addendum and allow to supervise the work of the CROs in efficient way, ensuring that all the quality requirements were met.
The CROs involved in this project are the leaders in the market and already have their own systems to manage clinical trials, however, they are providing study updates in their own format.
Our client identified Arithmos as the right partner in the conduction of vendor selection, due to the vast experience of our team which allowed us to drive this complex phase successfully and reduce the company’s internal effort and the impact on the business.
We have also supported the client in the implementation phase to guarantee the business continuity and focus on the project objectives and business goals.
The main challenge was engaging all the interested parties in the process of identifying and implementing the oversight technology solution:
- Stakeholders: customer, technology vendor, consulting suppliers, CROs
- Departments: R&D, ICT, CSV, Pharmacovigilance, QA, Legal, Procurement
Bridging the communication and functionality gap between the stakeholders was vitally important, as it allows:
- Avoiding the silos between the departments
- Considering all the expectations, choosing the solution that works the best across the company
- Reducing the risk of misalignments between company requirements and solution implemented
We divided the project in three phases:
- Business Requirements
- Vendor Selection and Assessment
- Vendor Confirmation
We have optimised the collection of business requirements while working with small groups from each department to define 5-7 key needs.
During the Vendor Selection and Assessment phase we have adopted a 5-step approach that allowed us to identify the best solutions that respond to the client’s key needs:
- Compiled a list of 3-5 vendors
- Carried out a survey to gather information regarding the size of the company, its capabilities, certifications, product history and roadmap, etc
- Requested demos focused on requirements collected from the client
- Requested ballparks
- Compiled an assessment report with evaluation matrix based on the survey and demo outcomes to identify vendor had the highest weighted score
Once the vendor was chosen, the client conducted an audit to verify the preferred vendor’s compliance and processes.
Structured analytical approach has allowed us to identify the right technology clinical oversight solution that satisfies the requirements of different stakeholders minimising the impact for all business area involved. The proposed solution:
- Gives a global overview of all the client’s vendors involved in each study
- Converts non-homogeneous data into a format that is homogeneous and allows easy comparison, control and performance analysis, for example the visit frequency analysis
Arithmos and the client have worked very closely and tirelessly to select a technology solution that allows to conduct oversight in an efficient way and in compliance with the ICH GCP E6 (R2) addendum. The selection phase was followed by Phase II (tool implementation) and Phase III (support and maintenance).
The relationship created and the collaboration and communication processes defined during the software vendor selection between Arithmos and the client have definitely added value to the following phases, shortening the organisational stage and related project risks and making the working team more efficient.