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We provide below mentioned services in Phase II / III / IV drug and medical device studies, stem cell therapy – regenerative medicines, Non Interventional / Observational Studies, Registry & Epidemiological Studies and Disease Surveillance Programs in various therapeutic areas. We have also expanded our services to BA/BE and Phase I Studies through strategic alliances with other CROs.

We ensure to deliver the project within allocated budget and defined timeline through meticulous planning and precise coordination without compromising the quality, patient safety and confidentiality.

Total Project Management

We diligently endeavor to ensure culmination of the Clinical Development projects within allocated budget and defined timelines through meticulous planning and synergistic coordination without compromising the quality, patient safety and confidentiality.
	Site Identification, Feasibility Assessment and Selection
	Recruitment of investigators through our direct contact and existing Investigator Database
	Subject Recruitment Plans and Implementation
	Investigators Meeting
	Trial Master File - Essential Documents Development
	Obtain IRB approval
	Site Initiation
	Training of all study personnel on protocols, Standard Operating Procedures (SOPs), Good Clinical
	Practices (GCPs) and all aspects of study management
	Ensure delivery of Study Materials at the site
	Drug / Device Accountability
	Project Status Reports and Newsletters
	ICH-GCP compliance Monitoring
	Safety and Quality Monitoring
	Data Query Trail Management
	Quality Assurance
	Study Close-out
	Site Payment Services

Regulatory Affairs Consulting

We assist Pharmaceutical Companies/Healthcare Organization in obtaining regulatory clearances after thoroughly understanding the Scientific literature/documents related to the Product/NCE/NBE/Device under consideration :
	Drug Controller General of India (DCGI) Approval
	Regulatory Dossier Compilation, Communication and application
	Regulatory Approval from DCGI for New Drugs, Medical Devices

	Directorate General of Foreign Trade (DGFT) Licenses
	DGFT Export License for Biological Specimen
	Import/T-license for New Drugs/Devices or Materials

	Indian Council of Medical Research (ICMR) Clearances
	Dossier Preparation, Communication and application for Vaccines/Biological Drugs /Cell
	Therapy/ Investigators Initiated or Collaborative Studies.

	Narcotics/Prohibited Substances Licenses/Permission

Insurance Procurement

Independent Ethics Committee (IEC) consultation

Clinical Research Training Solutions


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