Trial Management (TM)

Trial Management (TM)

  • STUDY DESIGN AND DEVELOPMENT
  • PROJECT MANAGEMENT
  • SITE MANAGEMENT
  • MONITORING
  • DATA MANAGEMENT

STUDY DESIGN AND DEVELOPMENT

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.

Biosite Research offers to:
  • Develop the protocol
  • Conduct protocol review
  • Develop the investigational plan
  • Design the case report form
  • Plan the collection of patient reported outcomes
  • Develop the statistical analysis plan
  • Develop the study materials
  • Plan and conduct the investigator meetings

PROJECT MANAGEMENT

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.

STUDY STARTUP

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.

PATIENT RECRUITMENT & RETENTION

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.

RECUITMENT & RETENTION TOOLS
  • Appropriate Site Selection for Quick Recruitment
  • Training of Site Staffs & Clinical Team
  • On-time Recruitment
  • Referrals
  • External Database
  • Investigator Networking

SITE MANAGEMENT

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.

Site Coordinator Services include:
  • Supporting investigators with patient recruitment
  • Administrative coordination of ethics committee submissions to hospitals
  • Support of the CRA during monitoring visits
  • Maintenance of the Investigator’s file
  • Coordination of patient visit schedules
  • Drug accountability and dispensing logs
  • Coordination of sample shipments
  • Payment of patient expenses
  • Supporting data entry/query resolution/SAE notification

MONITORING

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 :


  • Review and verify 100% of available source documentation.
  • Review all clinical data at the site for legibility, completeness, and consistency within the protocol.
  • Train site personnel as per requirement.
  • All monitoring visits are documented in a monitoring visit report and follow-up letter to the site.

DATA MANAGEMENT

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.

Our Services include:
  • Full service data management support
  • eCRF and paper design
  • Data Management Documentation (DMP, DVP, DMR, etc.)
  • Database set-up, Data Entry, Medical Coding, Data Validation and Cleaning
  • Reconciliation of lab, ECG, imaging data, etc.
  • SAE reconciliation
  • Support and training of investigators and monitors
  • Data Transfers
  • System Validation
  • Flexible data capture techniques across major EDC platforms
  • Databases are constructed according to CDASH (CDISC)

Our Locations

Bengaluru Office

#740, Second Floor, 14th Main, Police Station Road, Kumarswamy Layout, Stage 1, Bengaluru - 560078. (Karnataka) INDIA

Gurgaon Office

T 17/7, Second Floor, DLLF Phase 3, Gurgaon - 122010. (Haryana) INDIA

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