Feasibility Studies through
e-Feasibility
Phase I-IV studies
Project/Data Safety Management
Operational Management Team
Audit/Inspection Readiness
Training through ASSAY Academy
Independent Quality Assessments
Document Management through
GRAVITY
Monitoring
Regulatory
Consultation on protocol design in the operational perspective.
Upfront discussion on risks and challenges expected and recommendation / implementation of capa.
Creation of study-specific documents, worksheets and tools for use by the site and study team.
Recommendation and identification of facility(ies) or site(s) for healthy volunteers or a specific patient population.
Site feasibility and collection of essential documents.
Site initiation.
Study-specific document distribution.
Training of site and study team on protocol and study activities.
Essential document management.
Document amendments and its management.
Successfully assessing feasibility is a vital step before embarking on an expensive clinical trial. Making the right choices during site selection is key to the positive conduct of the trial. Our aim is to complete this phase quickly and effortlessly with quality results. e-Feasibility provides you the ability to create study specific questionnaires and share it with potential investigators and track the progress of completion. With robust reports, the project management team will find e-feasibility the perfect solution to recruit potential investigators to the study in the shortest possible time.
It can take many years for a molecule to travel from laboratory concept to marketed product. It is important that your molecule is given the utmost attention and support at every phase of its clinical trial journey. Whatever the therapeutic area or complexities of the new medicine, the goals are simple: establishing the fit for purpose balance in the safety and efficacy profile and so achieving approval in the minimum time and at the lowest cost. Whilst this is easier said than done, contact us to learn more or to get a quote.
Good management is bringing the right people and right ideas together at the right time and transforming thoughts into action and output. Our team of expert managers and their associates bring the best management practices to provide a quality outcome, efficiently and cost-effectively. Be it project management, data management or safety management, our dedicated team will handle and deliver every task within the stipulated timeframe and helping you achieve every project milestone.
Intensive ae and sae oversight and reporting.
Safety letter management.
Susars, psurs and final study report management.
Set-up of database and planning.
Forecasting site visits for completing source verification.
Database maintenance and query resolution.
Periodic safety analysis and data extraction for interim analysis.
Database cleaning and lock.
Detailed tracking and reporting of trial activities.
It can take many years for a molecule to travel from laboratory concept to marketed product. It is important that your molecule is given the utmost attention and support at every phase of its clinical trial journey. Whatever the therapeutic area or complexities of the new medicine, the goals are simple: establishing the fit for purpose balance in the safety and efficacy profile and so achieving approval in the minimum time and at the lowest cost. Whilst this is easier said than done, contact us to learn more or to get a quote.
CRA identification and training.
CRA authorization visits.
CRA quality assessment visits.
Successfully assessing feasibility is a vital step before embarking on an expensive clinical trial. Making the right choices during site selection is key to the positive conduct of the trial. Our aim is to complete this phase quickly and effortlessly with quality results. e-Feasibility provides you the ability to create study specific questionnaires and share it with potential investigators and track the progress of completion. With robust reports, the project management team will find e-feasibility the perfect solution to recruit potential investigators to the study in the shortest possible time.
Dedicated team to perform periodic checks and formal audits, both study and site level.
Implementation of corrective actions for the findings.
Preparation for inspection readiness
In clinical research, being organised is a prerequisite of success. Bringing the right resources to bear at the right time is a challenge. This is particularly applicable for document management for a clinical trial. GRAVITY is your long-time solution for site file and trial master file management. We have converted both files into easy to manage, co-ordinated electronic format. This integrated package facilitates logical and convenient document management.
The constant ongoing training requirements of the clinical research environment can be stressful and could eventually drain the energy of even the most committed employees. Successful training should energise and enhance the learner’s abilities. When the process of training and tracking is simplified, the result is usually enhanced engagement. ASSAY Academy is our unique single window training management system for project team and site team to train and track project specific trainings with ease.
Our services would not be complete without our expert regulatory consultation and process evaluation. Every clinical trial application submitted by us to the regulatory authorities and ethics committees is rigorously scrutinised. That way you can be sure that the appropriate permissions are granted as early as possible. We are also able to submit your drug information for marketing licenses. Name the country and we will ensure that your clinical trial or drug is successfully submitted for approval.
Consultation of suitable countries based on regulatory framework and timelines.
Planning regulatory / ethics committee / irb submissions based on the timelines.
Ind submissions, preparation of summary of product characterisation (smpc),import/export licenses.
Preparation of documents for submission.
Coordinating for query resolution towards securing timely approval.
Study document amendment management.
We do not do just monitoring. At ASSAY, we insist on fit for purpose cost-effective monitoring. Our monitoring services include, routine monitoring, risk-based monitoring, remote monitoring and project tailored monitoring. We support our monitors with the necessary tools and training to effectively utilize on-site time and prioritize activities. The ASSAY project team will also be closely assessing the outcome of each activity and performing trend analysis to tackle and resolve issues in the shortest timeframe.
Overseeing trial progress.
Forecasting site visits for completing source verification.
Site document management.
Site training.
Early detection of risk factors and implementation of capa.
Detailed tracking and reporting of trial activities.
