AcceleROUTE™ team is working along four well defined Streams:
We integrated these four critical phases under one umbrella to ensure a sustained pace and consistent quality across the whole lifecycle of your study.
1.The Feasibility & Site Selection Stream
Access to patients, accelerated recruitment, and efficient patient retention are the most crucial issues in modern clinical trial management. We take patient recruitment very seriously. The basic pre-condition for a successful recruitment is precise and considered site selection. We make all efforts from the very beginning, identifying the optimum site portfolio for your trial, selecting the best-performing trial sites. Utilizing the advantage of having a robust site/investigator database at hand is a result of our 20+ years existence in clinical research. This database is continually updated with data from previous recruitments, quality issues, IRB/EC specifics, contracting challenges, access to patient data, available diagnostics tools, patient characteristics, therapeutic guidelines and standards, and other relevant data as appropriate. Our dedicated Feasibility Team performs a very detailed assessment of the trial reasonability , investigating the competitive trials, diagnostics/medical challenges, regulatory landscape, logistical requirements, and other factors as appropriate. Based on the results of this analysis, we build an IDEAL SITE PROFILE model.
Based on the collected feasibility survey data, we determine the most relevant recruitment impact factors and based on this data, we perform a recruitment simulation to better understand the impact of different risk/impact factors and how manipulation of those factors may influence the final recruitment outcome.
2.The Recruitment Stream
The most significant cost generator in a study is extended recruitment. One of the primary reasons for early study termination is the delay in recruitment. However, there is no single solution to this significant issue, as there are many reasons for sub-optimal clinical trial recruitment. Each clinical trial bears a unique set of problems and, challenges, study objectives, and includes diverse stakeholders that will need to be engaged. However, with our pragmatic approach, we can minimize these risks by identifying and understanding the complex dynamics of relevant recruitment impact factors through our proprietary Recruitment Simulation method. Any changes to these impact factors may affect the recruitment outcome; hence, if any corrective actions are required, they will be visible in our simulation on time, even before we see any changes in the number of forecasted patients. With the understanding of the relevance of individual or combination of impact factors, we are in a better position to address the issues and correct delays in recruitment specifically.
3.The Startup Stream
Delayed study site activation is a significant budget burner. We devote meaningful efforts to coordinating the essential document collection, review, filing, compilation into submission packages, investigational product release, and others. These crucial processes in study startup involve a lot of administrative paper-based work. Any delay, negligence, or document quality issues may cause significant delays in study approval and startup.
The other significant drawback in site activation could be the site contract negotiation and execution. This process requires an in-depth understanding of local legal and individual site or investigators' requirements. Not respecting local specifics like indemnification rules, insurance coverage, confidentiality, GDPR aspects, or others could cause unpredictable delays very often.
The third critical aspect in the efficient study startup is the timely Vendor alignment which often includes vendor selection and qualification, contracting, onboarding, study specific training. Several vendors must act in the earliest phase of the project lifecycle to ensure a smooth study start. Those critical vendor activities include but are not limited to drug packaging and labeling, IVRS system setup, clinical database setup, calibration of imaging instruments, validation of particular laboratory assays, laboratory kit assembly, translation, and many other study-specific activities.
Accelsiors is well prepared for all these challenges. Our dedicated Startup Stream Team is the most robust group within AcceleROUTE™. The Startup Stream commences its activities immediately following the project Kickoff meeting. These are comprised of Site Contract Specialists, Record Management Specialists, Vendor and Supply Specialists, Regulatory Specialists, where required, Dedicated field-based CRAs or other team members. They work under the supervision of dedicated startup leaders, ensuring the finest coordination of all these diverse activities for timely site activation. Our advance clinical research technologies, like our electronic management system, CTMS, different communication platforms, fully support the work of our Startup Stream Team.
4.The Study Closure Stream
Database lock is, without a doubt, the most critical milestone in a clinical trial, upon which all further data analyses and reporting timelines depend. There is a common misconception that Data Management is solely responsible for steering the data management process to ensure the database lock happens within an agreed timeframe without any issues. The other misconception is that preparation for database lock should start just weeks before the last patient is out. As a result of these misconceptions, database lock is often performed with a high level of stress, resulting in frequent overtime work, shifting resources, ad-hoc decisions, etc. Unfortunately, it is not uncommon that the combination of these factors sometimes negatively impacts data integrity, which may result in one or more database unlocks. Re-opening of a database causes substantial delays in data analysis and reporting. Moreover, and perhaps more importantly, it severely impacts the project team's confidence in the data itself.
At Accelsiors, preparation for the database lock and consequent study closure is shifted towards the study initiation part in the study's lifecycle. In essence, a successful database lock can only be achieved if the study setup (including, but not limited to database setup activities) has been performed to the highest standard by using the QbD approach. Upon enrollment of the first subject into the trial, Accelsiors Study Closure Stream Team, under the direction of project management and data management representatives, will boost the pre-planned and organized activities to achieve the scheduled study milestones. The team ensures the collected data continually meets the data integrity requirements to perform a timely, smooth, and successful database lock.