Clinical Trial Management

8C Healthcare specialises in Medical Device Clinical Development with over 12 years of experience.  Our regulatory and operations teams extend their support by working like your extended team in designing and conducting Clinical Trials in India. Our distinctive combination of competencies supports your project in most complete and extensive manner.  

Clinical Study Management

Delivering projects efficiently, on time and on budget

Our experienced and highly qualified clinical managers ensure that your study objectives and timelines are met.

Clinical research consists of continuously evolving aspects, like regulations, guidance, and expertise, making efficient clinical study management, demanding in all respects. The intricacies in driving an investigational device from inception to regulatory approval has increased many-fold over the years. The composite nature of clinical trials requires project managers with extensive skills in regulatory compliance, safety monitoring, data management, financial management, effective participant recruitment, and participant protection.

Our experienced team develops the Clinical Trial Agreements (CTAs), specifically matching  the client’s requirements and needs. The team strategically negotiates study budgets by conducting frequent communication and establishing trustworthy relationships with sponsors, investigators and hospitals.

Our clinical project manager acts as a single point of contact making sure that the goals and objectives of your clinical trial are properly communicated and successfully achieved. The Clinical Project Manager will assure that all ethical, financial, and scientific requirements laid out in the clinical study protocol are accomplished by tracking and managing study metrics such as, participant enrolment status, filing essential documents, monitoring, CRF tracking, data queries, and adverse events.

8C Healthcare provides comprehensive clinical study management services with a focus on the safety  and well-being of study participants. We offer these services as a turn-key package for the overall management of your study, or on a selective basis when only specific CRO services are required.

The services are broadly classified in the following stages of clinical study, they are: 

Site Selection

  • Relationship with the Physicians
  • Enrolment Rate
  • Retention Duration
  • Data Quality

Study Start-up

  • Contract and budget finalization
  • Site feasibility assessment and selection
  • Investigator selection
  • GCP training
  • Creation of all applicable regulatory documentation
  • Planning of Investigator(s) meeting
  • Development of advertising material for the recruitment of Study participants

Study Maintenance

  • Organizing study communications between sites and sponsor
  • IRB/EC/Regulatory coordination
  • SAE management
  • On-Site and central monitoring
  • Management of clinical trial supplies
  • CRF maintenance i.e., data query generation and resolution

Study Closure

  • Site close-out activities
  • Data query resolution
  • AE resolution
  • TMF closure
  • IRB/EC/Regulatory reporting
  • Accountability and returning/destruction of Investigational devices

Clinical Trial Monitoring

Integrating the strengths of people and process to improve patient safety and data quality

Our clinical monitoring is conducted in accordance with a well-designed monitoring plan, ICH-GCP Guidelines and applicable regulatory requirements.

We offer both on-site and centralized study monitoring services at 8C Healthcare, based on the requirements and risks of your clinical trial. The implementation of risk-based strategies as well as central and on-site monitoring services ensures that all data is collected in accordance with the clinical study protocol/Clinical Investigation Plan and that the rights and safety of participants are protected.

Clinical Research Associate (CRA)  recognizes the study objectives, efficacy, safety aspects and CRA team proactively identifies and manages the study according to critical data and processes. Our CRA work as the crucial confluence between the project team and the Investigator, exhibit high levels of site management skills to ensure that the issues at sites are addressed swiftly & completely and maximize data quality.

CRA’s at 8C Healthcare channelize their efforts to acknowledge the complex issues of the protocol and indications, verifying site compliance, risk mitigation and maintaining strong site staff relationships. Our clinical trial monitoring model include CRC selection, initial and ongoing training, study and site resourcing, quality oversight and continued development. CRAs execute all activities related to qualification visits, initiation visits, interim monitoring visits, and closeout visits, ensuring compliance to the protocol/clinical investigation plan and all applicable regulatory requirements.

On-Site Monitoring

  • Site qualification visits
  • Site initiation visits
  • Site interim monitoring visits
  • Site close-out visits

Central Monitoring

  • Data quality, oversight
  • Triggered monitoring
  • Remote monitoring

Data Quality Assurance

Absence of errors that matters

The stringent regulatory compliance requirements in medical devices demands an effective quality assurance without any compromises. Our QA team understands this, and we offer the following study specific auditing services to ensure the integrity of your studies. The services are:

  • Investigative Site Audits
  • Trial Master File Audits and
  • Routine & For Cause Site Audits.