PHASE II-IV CLINICAL TRIALS 

 

PROJECT MANAGEMENT

Through strong team system, close communication, and elaborated tracking and measurement, the Project Management group delivers consistent high quality services to clients.

Projects vary based on size, complexity, therapeutic area and specific client requirements. All projects conducted by KPSCS, whether with a single service scope of work or a full-service global program; follow a common project management methodology that provides sponsors with a standardized and disciplined approach to project management. This methodology provides each Project Manager with a set of standards and guidelines to manage projects in the most effective manner.

Project Managers have the background and skills necessary to effectively manage the following important project management components:

  1. Customer relationships and communication
  2. Developing and executing customer-specific requirements
  3. Effective Project planning and scheduling
  4. Project Resource Planning and allocation
  5. Project Risk Planning and Analysis
  6. Project Budgeting
  7. Project Communication
  8. Project tracking and status reporting
  9. Proactive issue identification and resolution

CLINICAL TRIAL MONITORING

KPSCS provides Clinical Monitoring services via office-based and regional Clinical Research Associates with a smooth flow of active communication amongst project team members. The Site Monitors are ICH-GCP trained and provided with trial specific and Sponsor's SOP training (if required). The approach of each site monitor is for 'site oversight- they are responsible for the efficient supervision of the site team, site team personnel training, the resources available at the site, and the timelines set for the study milestones at the site.
 
KPSCS offers high quality solutions driven by the combination of clinical trial expertise and resources that facilitate the collection and review of paper or electronic patient data in clinical trials.

Study monitoring services offered by KPSCS are tailored to meet the objectives, design and requirements of Sponsors, and are characterized by planning, versatility, reliability, scalability, and the ability to interface with other participating vendors, all in compliance with stringent confidentiality and applicable local regulatory standards.

 

CLINICAL TRIAL SITE MANAGEMENT

The site qualification process ensures that sites meet the necessary requirements of the trial prior to study site initiation. KPSCS has an extensive database of investigators in several disease domains that consist of physicians with extensive clinical trial experience. These investigators have the appropriate facilities and qualified support personnel, and are audited and approved by KPSCS and thoroughly trained in Good Clinical Practices as well as on trial procedures and requirements.




GCP Guideline workshop:


KPSCS offers a one day workshop in various cities in India as well as on request of an individual organization / institution.

Site Management Training workshop:

KPSCS offers a two days workshop in various cities in India as well as on request of an individual organization / institution.