Outsourcing solutions are becoming increasingly important in the context of clinical development projects. It is becoming increasingly difficult to select the right partner who can responsibly manage the content, time, and financial aspects of the collaboration.
The OutsourcingTriologie is a professional Navigator in the search, selection, and implementation of flexible capacity solutions. We develop tailor-made strategies to strengthen your performance capabilities and offer support in outsourcing clinical research and development programms.
Successful implementation requires a broad range of specialist knowledge and expertise, which is part of the know-how of the OutsourcingTriologie experts. Many years of experience in the field of outsourcing on the pharmaceutical and CRO side and activities in management positions complete the range of expertise. OutsourcingTriologie develops customized outsourcing strategies through to market approval in order to improve performance and thus counter time and cost pressures with professionalism.
Each solution by OutsourcingTriologie offers different benefits and considerations in terms of cost savings, access to specialized skills, proximity, cultural alignment, and control. By understanding the outsourcing spectrum, businesses can tailor their outsourcing strategy to meet the client specific needs and objectives effectively.
Additionally, outsourcing provides flexible resource allocation and access to innovative technologies, further enhancing efficiency and speeding up data analysis. Overall, utilising outsourcing in clinical research can help companies expedite the drug development process and ultimately deliver new treatments to patients faster and with the support of OutsourcingTriologie companies can concentrate on their core competences.
Outsourcing budget planning can be a strategic approach and advantage for Pharma and Biotech companies prior to initiation of a clinical trial.
In a close cooperation with a Biotech company, OutsourcingTriologie compiled a ballpark figure and a detailed budget overview of the potential Clinical Research Orginisation (CRO) costs of outsourcing defined tasks for a Phase II trial. The initial cost estimate only deviated marginally from the overall final cost proposal of the selected CRO. This successful cooperation resulted in a strategic partnership.
During the start-up phase of a clinical trial in particular, internal resources for the CRO selection process must be allocated by Pharma/Biotech according to regulatory requirements and tasks prioritized.
Based on their experience in various CRO selection processes, Clinical Research Experts from OutsourcingTriologie were able to support a Biotech company with the CRO selection process within challenging timelines. The planned Kick-off date was successful reached.
A full-service approach for a CRO encompasses a comprehensive range of services to support clinical trials. In such an approach, where a CRO is engaged to manage most of the aspects of the trial on behalf of the sponsor, sponsor oversight remains crucial.
Based on their experience in various CRO selection processes for a fully-outsourced model, Clinical Research Experts from OutsourcingTriologie were able to support a Biotech company with enthusiasm and team spirit during the entire selection process from start until completion of the selection process. Quality oversight measurements were also successfully implemented.
BID Defense Meetings in clinical trials require high-level professional support across various departments including Clinical Research, Medical Affairs, Regulatory, Data Management, Biostatistics and Legal.
OutsourcingTriologie ensured alignment with regulatory requirements, accurate data analysis, effective project coordination and legal compliance through active involvement on behalf of a sponsor in BID Defense Meetings for a Phase III clinical trial. By minimising BID Grid related project tasks that did not result in any benefit at project level, a 21% reduction in the planned CRO budget was achieved without any compromises in quality.
Third-party contract management involves overseeing contracts with external parties throughout their clinical development activities by Pharma and Biotech companies and includes drafting, negotiation, execution, compliance monitoring, risk management and performance evaluation.
Effective management by OutsourcingTriologie ensured that contractual obligations were met within short timelines, risks were minimized, and performances were optimized in interactions with all involved parties. This required robust processes, tools and communication skills and resulted in customer fulfilment.
Due to different factors ranging from performance issues, financial considerations or to capacity constraints, a CRO transition during an active clinical trial may be planned by a Pharma or Biotech company.
A process manual for the transition period and a Task Road Map (utilized as a living document) were developed by OutsourcingTriologie; key steps for adapted selection process and key responsibilities were defined. After the successful transition period, a post-transition evaluation for process improvement was established in a close cooperation with the sponsor. Effective communication with all stakeholders and deployment of best practices ensured the continued success of the clinical trial(s).
A CRO can become insolvent for a variety of reasons, including financial problems, loss of key clients, litigation, miscalculations, regulatory problems, poor business practices and market changes. Insolvency during an active clinical trial with patient/subject enrollment immediately requires a takeover by another CRO.
Due to such a scenario occurring, OutsourcingTriologie was responsible for developing an emergency contingency plan and an implementation plan in a very close cooperation with a Big Pharma company within a minimal time frame. Due to a broad spectrum of experience in clinical trials, risk management approaches and structured process documentation, the Emergency Plan implementation acted as the basis for a successful transfer of the CRO’s activities.
Developing a SOP Landscape for selecting Contract Research Organizations is crucial for ensuring efficiency, transparency, and quality in clinical trials worldwide. Therefore, a structured approach, including sponsor oversight, is needed.
OutsourcingTriologie was contracted as an independent consultant to develop a SOP Landscape for the entire CRO selection for a Biotech company including a pro/con analysis. After implementation, the entire team on project level was trained to fulfill the requirements. The customer appreciation received after this successful implementation was motivation for the entire Triologie team.
Due to the regulatory landscape, project requirements, budget development, resource planning and quality oversight measurements, high level project management is needed.
OutsourcingTriologie team members understood what was required for the CRO selection processes and corresponding activites. The comprehensive knowledge of entire clinical trial environment and the ability to “think outside the box” were successful provided by the OutsourcingTriologie project team on different selection processes with high quality results and successful transitions. Patient and subject safety within the respective trials were ensured at each stage of the Project Management process.