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| Home > How We Do It |
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| How We Do It |
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Domain Focus
Karmic has a team of medical advisors and domain experts with a cumulative domain experience of over 250+ person
years including Regulatory (USFDA, EMEA, Indian DCGI, Unregulated Markets) and Medical (Clinical Pharmacology,
Clinical Research, Pharmacy) experience.
- Our Clinical Trial Management team further has direct hands-on experience on multiple therapeutic areas
including Oncology, Diabetes, Cardiovascular etc.
- Our Medical Writing team has handled over 50 Protocols, 20 Study Reports and several CRF/ICF design and medical
manuscripts.
- Our Regulatory Experts have cumulatively handled over 25 NDA/ANDA submissions for USFDA and EMEA.
- Our Clinical Data Management group has hands-on experience of 21 CFR Part 11 compliant client server based and
EDC systems including ClinTrial, Oracle Clinical, Medidata Rave (EDC), Inform (EDC) and other systems including
SAS (Statistical Analysis), KnowledgeNet (eCTD) and MedDRA (Medical Dictionary).
We hence have a strong domain focus and thereby add significant value to all our projects.
Well Documented SOPs
Karmic has a suite of over 100 SOPs to address all aspects of clinical trial management. These SOPs are created
by clinical research practitioners with several years of clinical experience and deep insight into global best
practices and practical aspects of running a trial. Our SOPs are version controlled and updated once every year.
Each and every employee is trained on all relevant SOPs before he/she starts an assignment.
Rigorous Training
Karmic has a comprehensive training program covering all aspects of clinical trial and data management wherein
each and every employee goes through a mandatory 200 man-hours training on an annual basis. Our training
includes a rigorous 10 day induction training program covering various clinical topics including Trial Design,
Trial Initiation and Conduct, Trial Audits, Data Management, Bio-Statistics, Medical Coding, Medical Writing etc
. The training also includes several hands-on modules and exercises. This is followed by monthly refresher
training, focus training to address performance concerns and special training programs to cover specialized
clinical topics including Pharmacovigilance, CDISC compliance etc.
Regulatory Compliance
Karmic manages all its projects in full compliance with various global and local regulatory guidelines including
ICH-GCP, Indian GCP, Schedule Y, 21 CFR Part 11 etc. Our experts have deep insight into regulatory requirements
and ensure that all our project documentation and implementation is in line with established norms.
Confidentiality and IP Protection Norms
Karmic applies strong controls to protect internal as well as external client data. Some measures include having
formal confidentiality agreements with all clients, employees and vendors, having strict physical and data
security norms including comprehensive IT and E-mail Policy, frisking of employees, electronic access controls,
ban on all electronic storage media in office premises (including CDs/DVD/USB Drives/External Disks etc.),
restricted access to all sensitive areas including central archival, server and networking areas, secure ftp
and firewalls etc.
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| Featured Case Study |
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| Karmic currently supports a Top 5 Global Pharmaceutical giant for data management across 15+ studies in multiple therapeutic areas over 14+ geographies across the globe |
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| read more >> |
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