At MedHimalayas we aim at project-specific management. We assign a highly efficient, qualified and experienced team for each project based on therapeutic area expertise.The Clinical Operations Manager oversees all projects ensuring their timely progression and accuracy.
We tailor our approach to deliver projects in accordance with specific study requirements and timelines without compromising quality , patient safety and confidentiality. We achieve this by emphasizing on the following components within project management.
Strong customer focused approach with quick and effective communication
Investigator selection from our database and training
Project feasibility studies
Assign project specific manager and team
Develop project governance plan
Project specific patient recruitment and retention
Project resource allocation
Project risk analysis and management
Project budget and timeframe management
Management of flexible in-house project tracking system
MedHimalayas provide clinical monitoring services by trial specific Clinical Research Associates . The monitors are ICH-GCP trained and work closely with the investigation sites to achieve quality results.
Site identification
Feasibility assessment and selection
Investigator team training
Site initiation and review of regulatory documents
Safety and quality monitoring including source and regulatory documents review, data retrieval, SAE reporting, assessment of protocol adherence and Investigational Product accountability.
Regulatory affairs is an integral and crucial part of MedHimalayas Clinical Research management, ensuring compliance with all relevant regulatory requirements in all stages of every project. Our Regulatory Affairs experts possess extensive knowledge of the regulatory environment and the changing requirements in many countries and regions. They work meticulously in expediting the processes without compromising quality.
CRO Services