Life Science Capabilities / Clinical Operations
Ideate, Design, Plan, and Oversee the conduct of BE, Clinical, and Non-Clinical Studies.
Clinical trials
Clinical Program Development & Management
BE Studies
Regulatory Queries
SmPC & PIL reviews
Consulting
Audit and Due diligence
Pre-clinical studies for molecules
In-vitro studies
Medical writing
Setting up quality by design procedures
Regulatory queries Training for GxP activities
Team experience & expertise
Team comprises research scientists with PhDs & medically qualified professionals including those with advanced degrees in dentistry and pharmacy having average team experience of 15+ years
Strong Vendor Management with CROs
Preferential allocation of study slots on discounted rates in comparison to market
Clinical advise for development of new molecules
Team comprises research scientists with PhDs & medically qualified professionals including those with advanced degrees in dentistry and pharmacy having average team experience of 15+ years
Mobile Clinical Services
With a national presence spanning over 20 sites across India and a team of more than 80 specially trained study nurses, we offer an extensive range of services, including:
Study drug administration (infusion, injection, topical)
Blood draws (Required as per protocol)
Other biologic sampling (e.g., nasopharyngeal and oral mucosal swabs, urine, etc.)
Clinical assessments (vital signs, body weight, ECGs, concomitant medications, signs/symptoms, etc.)
Patient training and education (self-administration, use of devices, etc.)
Study compliance checks (patient diary, drug storage, etc.)
Patient questionnaires
Site (staff) support services
SOPs are developed at every stage.
Expert nurses trained in GCP & documentation.
High-quality patient care delivery and data collection.
Reports are shared as per agreement with the sponsor.
Maintenance of records & patient data are compliant with international standards.
Patient Consents to Home Visits
PI Sends & Study Coordinator Receives Service Request Form
Investigator Site Initiates Mobile Clinical Services Workflow
Local Service Provider Identification, Qualification and Training
Investigator Site Receives, Reviews & Files Documentation
May occur before request if Local Service Provider is pre-identified
Local Service Provider Schedules Visit
Local Service Provider engages patient directly to schedule and receives supplies
Local Service Provider Conducts Visit
Local Service Provider travels to patient's location and conducts visit per request form including shipment of samples to laboratories through cold chain management
Laboratory Kit / Supply Shipment to Local Service Provider provided by Study coordinator or SITE
Investigator site receives visit source documents and laboratory results
Sites are responsible to report any AEs/SAEs and EDC entry
Local Service Provider Sends Source data to Site and scan copy to Study Coordinator