At DiagnoSearch, we strongly believe that a sound knowledge-base, meticulous planning and seamless execution in compliance with applicable regulations is critical to the success of each clinical trial. For us, at DiagnoSearch, every single project is uniquely important and requires a dedicated and focussed team spearheaded by leaders with appropriate experience and commitment.
Feasibility and site selection
Core documents review and finalization
Monitoring - Site Initiation, Site Monitoring and Close-out
Preparation of Investigational Product Management Plan
Finalization and coordination with comparator procurement organisations
Finalization and management of labelling and packaging vendors
Ensure availability of site supplies as per recruitment and subject progression
Evaluation of vendors
Our Clinical Operations Team gets involved in the project from early stages of discussions with the client. The assigned Project Manager is the single point contact for the client. Our robust internal processes and experienced team supported by fully customised technological tools like CTMS and eTMF helps the initiation of a project in expedited manner by ensuring quick turnaround of the following start-up activities:
Finalization of core study documents
Finalization of Informed Consent Documents and translations management
Resource allocation and study specific training
Site identification and qualification
Collation of Site Regulatory Package documents
Regulatory Dossier preparation, submissions and follow up till approval
Ethics Committee submission and follow up till approval
Study Plans (Risk Management Plan, Project Management Plan, Monitoring Plan, Communication Plan, Study Manual, Investigational Product Management Plan)
Review of Case Report Forms, IWRS specifications
Site budgets and Clinical Trial Agreements
Investigator Meeting planning and execution
Procurement and distribution of Clinical Trial Supplies
Selection and management of third party vendors
Here are a few factors which we consider critical for the success of the projects:
Selection of appropriate sites: The database of investigator sites and established site relationships help the project team while approaching appropriate sites as per the project requirements. In addition to the sites' past performance, we critically evaluate its infrastructure and resource experience for every new project. The sites’ potential subject recruitment rate is arrived at by using a scientific funnel-based approach. Our historical margin of error in projected versus actual subject recruitment is < 5%.
Site Training: Though Investigator Meetings and Initiation Visits provide a platform for detailed training, at DiagnoSearch we host an online training portal to address the need for role-based and project specific training with provision for evaluations and re-evaluation. The system issues training completion certificates only post evaluations. ‘Train the Trainer’ and web-based training have proven to be very effective for large field-based or resource intensive/long term projects.
Strict adherence to timelines: In the current highly competitive world of research and development, compliance to timelines is given. In more than 95% of the projects, we have achieved the start-up as well as recruitment timelines as per the plan, across therapeutic areas and phases of development.
Alignment of all the stakeholders on data capture and presentation: Nothing works better than “Right the First Time” approach as that prevents unforeseen challenges and re-work during execution. DiagnoSearch core project team ensures that the internal as well as external stakeholders are aligned on the data capture requirements at the beginning of each project.
Risk Based Monitoring Approach: Over the last few years, process of monitoring of the trial data is undergoing a pragmatic shift from 100% on-site Source Data Verification to a Risk Based Monitoring approach. The TransCelerate initiatives and global regulatory agency guidelines in this regard helped organisations to focus their attention on designing technological solutions and aligning their processes to achieve more credible data in real time. At DiagnoSearch, we focus strategically on identification of risks prior to study start. The Risk Management process is defined on the basis of the following principles:
The evaluation of risk is based on scientific knowledge and ultimately links to the protection of patient safety and well-being as well as key objectives of the project.
The level of effort, cost and documentation of quality Risk Management process is commensurate with the level of risk.
Quality risk assessments begin with a well-defined problem description or risk question. Failure Mode and Effects Analysis (FMEA) method is used to evaluate risks associated with the implementation of the project. It is based on the concept that a risk is related not only to the probability of failure occurring, but also to the severity of the failure’s consequences and the likelihood of detecting and intercepting a failure before it occurs.
Risk Review/Monitoring is an ongoing part of the Risk Management process to evaluate status of already identified risks and to provide platform for identification of new risks emerging during the life cycle of the project. The new knowledge and experience helps the study team members to identify new risks for the project. On the monitoring front, based on risk assessment, we develop monitoring objectives which include remote data review and percentage based on-site monitoring approach for Source Data Verification of critical as well as non-critical data. This allows us to focus more energies on review of critical trial data and achieve more credible data in a timely and cost effective manner. This process enhances the importance of holistic review of data by implementing data reduction techniques, which resulted in the introduction of ‘Wide-Angle-Data’.
Wide-Angle-Data is a Central, Integrated Data Review Platform that uses Risk Management principles based on ISO 31010 guidelines as the central theme. Data from different sources are integrated on a single review platform providing an opportunity to remotely review study data in a real-time setting. The data reduction techniques and simultaneous real-time data review by key study personnel ensures subject safety and data quality. In addition, early identification of study trends and risks enables a decision-maker’s timely intervention in order to positively influence study outcomes and significantly impact timelines and costs.