Clinical Trial Management

Feasibility Studies through e-Feasibility

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.

Phase I-IV studies

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.

Project/Data/Safety Management

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.

Operational Management Team

As individuals we may have come far, but we have usually not come alone. There has usually been someone to assist us, albeit in small or major ways. Our operational team take a holistic view of projects, ensuring good work-life balance, which ultimately contributes to a sustained, higher-quality outcome.

Audit/Inspection Readiness

One secret of success in clinical research is in being prepared for what is to come. At ASSAY, we can help you stay ready for an audit or inspection and provide expert recommendations on CAPA. Within ASSAY, our robust and advanced technology systems ensure that our trials are always audit / inspection ready.

Training through ASSAY Academy

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.

Independent Quality Assessments

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.

Document Management through GRAVITY

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.

Monitoring

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.

Regulatory

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.