Developing the right study design and a solid protocol is crucial to addressing a scientific question. To evaluate an investigational product against the standard of care, the study design and protocol have implications from the start to the end of a study.
Biosite Research’s services include both designing the study and protocol or reviewing the study protocol. Each protocol is developed with rigorous scientific principles to guarantee the highest degree of accuracy and to maintain current ethical standards. We ensure that the study design is in line with the brand strategy and internal review committee requirements in order to achieve a scientific objective. Our senior scientific members bring significant added value during the study design and protocol development with integrated insights from epidemiologists, biostatisticians, medical advisors and clinical operations experts.
Our study management approach is to be proactive and responsive with study sites.
As Project Management is all about real patient data, so our efforts are mostly aligned towards patient recruitment and retention. Project Managers work closely with sponsors to ensure that sponsor requirements are met in compliance with study timelines. Our project management team has been one of the success factors for past and current projects. The project managers are the central point of contact to improve studies’ efficiency and communication.
In addition, the Project Managers work closely with the sites to address potential issues before they occur, or to resolve issues before they escalate, which ensures timely and satisfactory completion of studies.
Biosite Start-up teams deliver a well-coordinated, collaborative, and customized approach that accelerates site initiation and is critical to every phase of global trials. Working closely with the top therapeutic and regulatory experts, our proficient, experienced, and dedicated team members engage quickly and provide strategic thinking – ensuring quicker start-up times than industry averages.
Biosite ensures patient recruitment and retention by providing strategic solutions with our multi-dimensional recruitment model. It enables us to implement innovative, comprehensive, and customized recruitment and retention strategies that identify, recruit, and retain members of specific patient populations.
BIOSITE Site Coordinators are GCP certified and become an essential part of the investigator’s team managing all logistics and administrative tasks for clinical projects. The BIOSITE Site Coordinators assure high quality trial data, assist in patient recruitment and compliance, reduce data-entry time for investigators and support successful study start-up and trial initiation.
During the last decade the process of clinical monitoring has changed significantly. Monitoring plays a major role in Clinical Trial for quality of Clinical data. We support sponsors to find the right balance of clinical on-site monitoring and remote monitoring activities to make sure that the best study quality can be reached according to the purpose of the study.
We provide and deliver Sponsor such monitoring Plan which is prepared by The Project manager based on continuous risk assessment approach. After approval from sponsor on site and remote monitoring schedule is prepared and shared with Sponsor.
By monitoring available data off-site or centrally, on-site monitoring is targeted to activities that cannot be performed remotely. We use a risk-based monitoring approach that is based on the FDA recommendations and guidelines for monitoring.
During on-site monitoring visits, our CRAs perform the following tasks to monitor compliance with GCP and local regulations :
Biosite has good amount of experience working with clinical data management utilizing a broad knowledge of different electronic data capture tools and paper-based trials. Biosite clinical databases and software are validated in compliance with Indian Regulatory, European, ICH-GCP and FDA standards.
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