Professional-level support, structured trainings and knowledge management are just as important as ever. Due to the regulatory requirements in the clinical environment and the challenges at project level, customized concepts and sustainable training are required. InnovationTriologie is your reliable partner to support you in this area with our broad spectrum of experience.
We work closely with your company to identify and establish customized solutions to ensure that the support you require is sustainable. In your day-to-day business, our commitment and focus on task completion provides you with a significant reduction in workload. This allows you to concentrate on your own work packages and receive the tailor-made support you need.
Motivating your team, providing project-specific training and delivering direct 1:1 support in clinical trials around the world are the key components that guarantee you a successful project delivery.
Targeted support for strategic projects or individual support services completes the range of services we offer.
Project Coaching is a particular strength of InnovationTriologie. Experienced project management experts can guide project managers through individual coaching or teams who still need support in order to achieve their goals within the agreed budget and at a high quality level.
Each member of our team has at least a decade of experience in drug development and is familiar with the business environment and requirements in the pharmaceutical industry, biotechnology companies and contract research organizations. This enables us to define quality over side measures with you and contribute to process optimization.
We can take responsibility for either partial strategic aspects or can support your program with a full development strategy and its implementation. You decide.
Our experience in day-to-day project work has shown that a prompt analysis of the necessary resources (human, financial and technical) is required in the event of constraints and time extensions in order to avoid delays to project progress.
Therefore, we have committed ourselves to FTR = first time right.
Due to various factors, plan changes were necessary to complete the Clinical project or program according to plan. From the necessity to select a new Clinical Research Organisation (CRO) at project level to a complex contingency plan for active trials with successful patient enrolment when the responsible CRO had to declare insolvency, the InnovationTriologie demonstrated a high level of commitment to get the clinical trial "back on track". Achieving the targets required a substantial and demanding workload. Within very short time frames and a structured roadmap in close co-operation with all parties involved, it was ensured that the defined objectives were achieved and our customers satisfied.
This service was requested by Biotech as well as Pharma companies.
The market situation, trial related timelines and total budget are important in this context. The consideration of trial related procedures and factors (e.g. Biomarkers) must also considered. A well-structured Clinical Development Plan, as part of the Development Strategy, was prepared in close cooperation with the responsible team when registering the intent to develop a new medicine or therapy. InnovationTriologie was also contracted as an independent consultant to support the Research Team and Leading Investigators on an equal basis with a broad range of experience. Our knowledge and experience of the time frames and processes at the Regulatory Authorities and Ethics Committees were beneficial in order to fulfill the procedures and requirements of the particular trial. Additional partners were selected and trained to provide immediate project support.
This service was requested by Biotech companies.
Due to regulatory landscape/applicable laws, project requirements and quality oversight measurements, experienced and well-trained Project Leaders at a “High Level” are needed. InnovationTriologie team members understood what is required for the clinical trial from the pre-start-up activities until the close-out procedures. The comprehensive knowledge of the entire trial environment and the ability to “think outside of the box” were successfully applied by the InnovationTriologie project team on different clinical trials across all medical areas. High quality results within the defined timelines and budget requirements were linked to the success of our customers and to repeat business supporting further projects over the years.
This service was requested by Biotech as well as Pharma companies.
The trial budget must reflect the full scope of all trial activities and anticipate situation/factors that could increase the expense of the entire project. Experienced leaders of InnovationTriologie were instrumental in supporting budget negotiations by providing a comprehensive approach. They started by meticulously planning the trial project, estimating costs, and conducting risk assessments. Effective communication with our customers ensured alignment on budget expectations. The InnovationTriologie team was also involved in managing the scope, resources and providing support in different budget negotiations. Continuous reporting via Monthly Progress Reports and close cooperation with the involved customer departments were success factors in different phases of a clinical trial.
This service was requested by Biotech as well as Pharma companies.
An important aspect of a clinical trial is the planning of all resources from the start. InnovationTriologie was contracted for different aspects of Resource Management. In close cooperation with our customers, resourcing strategies were defined with focus on the overall strategy. The contracted work packages included not only the requirements during the clinical trial, but also the performance of scouting interviews, selection of new employees and assigning available staff to defined project tasks. As part of a clinical development program, a customer-specific capacity database was developed in 2023 for oversight of the capacity requirements of an assigned function at any given time, including effective resource planning, on-demand forecasting, cost efficiency, informed decision-making, and risk management.
This service was requested by Biotech as well as Pharma companies.
The recruitment of subjects in clinical trials has been a key issue for many years. InnovationTriologie has been responsible for patient recruitment initiatives in many projects. Due to our network of research partners, opinion leaders and investigators from various specialist areas, including the expertise of our project teams, the required patient recruitment and patient retention rates were successfully achieved. Furthermore, the investigational sites were also trained/certified on ICH/GCP and other regulatory requirements by InnovationTriologie. Motivational visits and close communication with all investigational sites by the experienced InnovationTriologie leaders contributed to the success of these strategies. Innovative methods and novel concepts were used to develop customized solutions at a demonstrably high level of quality. Effective tools (e.g. newsletters) were designed and also included in the catalogue of the Recruitment Targeting Strategy.
This service was requested by Biotech as well as Pharma companies.
Starting a clinical trial is a multifaceted endeavor that requires meticulous planning, resources and expertise including collaboration with experienced clinical trial professionals, and regulatory experts. InnovationTriologie was requested to provide immediate support in start-up activities for different clinical trials. The development of a customized Start-Up Procedure Manual was the first step. In close consultation with the customer, this manual was finalized, time periods defined and responsibilities assigned before the different start-up activity tasks were implemented and the responsible experts allocated. Out-of-the-box solutions were approved by all parties upfront to optimize the particular timelines. The development of the Trial Protocol, an independent feasibility assessment, a structured site selection process with qualified Clinical Research Experts, professional study drug management, regulatory submission support and motivational site initiation were key success factors. Regular controlling and reporting of the individual tasks were part of the range of services spectrum that InnovationTriologie offers.
This service was requested by Biotech as well as Pharma companies.
The Due Diligence Process is critical for mitigating risks, uncovering potential issues, making informed decisions in drug development. This process requires expertise in science, law, finance and business strategy to ensure successful investments and/or partnerships. InnovationTriologie was contractually requested to initiate selected supporting measures on a high confidential level. The main focus was placed on the documentation of the processes/procedures/manuals at trial project level, the structuring of the various tasks and the assurance of the requested study documents in the respective Trial Master Files. As an independent partner, opportunities for implementation were discussed with our customers, improvements identified and realized.
This service was requested by Biotech companies only.
Due to the growing challenges in drug development, from data protection and special requirements for trial sites to the new regulatory requirements, experienced on-site support is required. All InnovationTriologie employees, including the management, have in-depth knowledge of clinical trial processes at the trial sites and have been able to ensure over the last 20 years that not only all trial protocol requirements are met, but also that investigators and site staff are trained to the highest level. The expert support in the field of inspection readiness ensured that the data collected was reliable and that all national/international regulatory requirements were fulfilled.
This service was requested by Biotech as well as Pharma companies.