Karmic Lifesciences is an ISO 9001:2000 accredited Clinical Research Organization with end-to-end expertise in providing Concept to Clinic services
for new drug development as well as generics. Our services include Pre-Clinical Support, Clinical Trial Management (Phase I to IV), Bio-Analytical
Services, Clinical Data Management, Bio-Statistics, Regulatory Consulting/Submissions and Pharmacovigilance services.
We bring together an experienced team of Clinical Pharmacologists (MD/PhD), Medical Monitors (MBBS Doctors), Bio-Statisticians (M.Sc. Statistics),
Site Coordinators, Project Managers, Clinical Research & Data Associates (B. Pharma/M. Pharma) with specialist experience across multiple
therapeutic areas including Oncology, Neurology , Cardiovascular, Diabetes, Orthopedic Ailments, Gastroenterology, Inflammatory Management,
Asthma and Ophthalmology to handle mission critical clinical engagements.
We have a robust network of over 500+ qualified sites, 1000+ Investigators and ICH-GCP/E6 trained Clinical Operations team with 2-8 years of field
experience across key therapeutic segments including Oncology, Neurology, Diabetes and HIV to jumpstart clinical trials. Our Site network includes
General Hospitals, Super Specialty Hospitals and Private Clinics on a pan-India basis across key cities including Mumbai, Pune, Bangalore, Delhi,
Chennai, Ahmedabad, Nasik, Bhopal, Patna, Kolkata, Cochin, Coimbatore, Hyderabad and Indore etc. We are further working on creating a captive
patient database of 3000+ patients in key disease segments in order to support our trial activity across Phase III & IV.
On the data management side, we support clinical back office projects through a fully secure, access controlled state-of-the-art delivery set-up in
Mumbai, India comprising best-in-class systems: ClinTrial 4.6 (Phase Forward’s CFR Part 11 compliant, fully validated, CDMS), Inform
(Phase Forward’s Electronic Data Capture Module) , SAS 9.1.3 (SAS Analytical Software Package), MedDRA 12.0 and WHO-DD medical dictionaries. We
further have a comprehensive suite of over 90 well-documented SOP’s to address each and every process in our project lifecycle. In order to further
strengthen our processes, Our Document Archival facility consists of an in-house access controlled, fire-proof, de-humidified, pest and insect
controlled Central Archival Unit with capacity to store upto ~ 1 Million CRF pages. We have further sub-contracted an additional facility through
our storage partners that meets defined GCP standards and can store upto ~ 5 Million CRF pages at anytime.
We further have strategic partnerships with USFDA/EUMHRA approved Bio-Analytical, GLP certified Pre-Clinical labs and CAP/CLIA certified central
labs for conducting Early Phase (I, IIa), BA/BE and Pre-Clinical studies while ensuring strict adherence to ICH-GCP standards.
We deliver our services on a strong platform of regulatory compliance and provide end-to-end regulatory support including Pre-Approval Dossier &
Documentation Support, Marketing Authorization Approval, Post Approval Support and Medical & Technical Writing services to our clients. Our team
consists of experienced regulatory consultants with 300+ person years experience and strong knowledge of USFDA, EUMHRA and unregulated markets.
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