Therapeutic Areas

Oncology

Practice Highlights

Globally, Oncology is the largest segment within pharma and at $ 56 Bn represents 7% of the global pharmaceutical market of $791.5 Bn (Source: IMS Health 2010 Report). Worldwide, 22 million people are living with cancer and cancer affects more than 10 million people every year. Currently, an astounding 32,644 cancer trials are registered on Clinicaltrials.gov and about 400 odd trials are being conducted in India. India has 2.7 Million Cancer Cases and an incidence of 1.1 Million new cases that represented almost 10% of the world’s cancer population. This coupled with leading cancer institutions and well- experienced Medical Oncologists makes India one of the fast emerging destination for cancer trials.

At Karmic, we consider ourselves an Oncology led CRO – Oncology is the core therapeutic focus area and flagship practice for Karmic and we have deep domain expertise and one of the most versatile body of experience in this area. Some of the highlights of our Oncology practice are:

• Strong domain expertise with experience of 11 completed Oncology Studies and 5 studies in ongoing stageacross 8+ Oncology indications including Metastatic Breast Cancer, Colon Cancer, Colorectal Cancer, Prostrate Cancer, Pancreatic Cancer, Ovarian Cancer, Non Small Cell Lung Cancer and Thrombocytopenia
• Robust team of Medical Oncologists on Scientific Advisory Panel, Oncology Project Managers, CRAs and Statisticians with strong knowledge of Recist 1.1 Criteria, Efficacy & Safety End-Points, Oncology Biomarkers (CA 19.9, CA 125, sVEGFR1, PSA, HER2, Serum Estradiol etc.), Novel Oncology Diagnostic Platforms, Centralized Radiology Scan reviews etc.
• Extensive network of over 136 Oncology Sites and 231 Investigators including KoLs at Top 10 institutional sites and leading with access to a large patient poolof 1 Mn+ Cancer Patients and CancerRegistries/Referral Centers for rapid patient enrolment

Illustrative Oncology Programs

Cardiovascular

Practice Highlights

Estimated at $150 Mn+ in 2010 globally, Cardiovascularis the largest therapeutic segment ahead of Oncology and Central Nervous System. As per WHO, over 17 Million deaths annually happen on account of Cardiovascular Disease. Currently, 21, 245 Cardiovascular Trials are registered on Clinicaltrials.gov and about 360 odd trials are being conducted in India. At 100 Million patients, India represents almost 60% of global CVS patient population and given the precedence of several large Cardiovascular trials being run in India, it is an important therapeutic area for Karmic. Some of the highlights of our Cardiovascular practice are:

• Strong domain expertise with experience of 14 completed Cardiovascular Studies and 5 studies in ongoing stage across multiple Cardiovascular indications including Coronary Artery Disease,Dyslipidemia, Chronic Stable Angina, Heart Failure, Myocardial Infarction, Hypertension,as well as drug eluting Coronary Stents, Peripheral and AV Shunt Devices
• Extensive network of over 129Cardiology Sites including key institutional sites and 100+ Investigators, Leading Interventional Cardiologists and KoLson Scientific Advisory Panel
• Strong partnership with Centralized ECG units for 24X7 Cardiac Monitoring and Central Labs for quick turnaround of clinical sample processing
• Extensive use of Health Awareness and Check-up Camps and Pre-screened Patients Databases for rapid patient enrolment

Illustrative Cardiovascular Programs

Endocrinology

Practice Highlights

At an estimated $ 32.43 Bn, Endocrinology isanother large segment with the global diabetic population estimated at roughly 285 Million in 2010 and India with 50.8 Bn patients tops the list as per WHO. Currently more than 7805 endocrinology trials are taking place globally with approximately 279 trials in India as per data available from clinicaltrials.gov. Given the high diabetes incidence and patient population, India continues to be an important hub for diabetes and Karmic has strong Endocrinology trials experience. Some of the highlights of our Endocrinology practice are:

• Strong domain expertise with experience of 7 completed Endocrinology Studies and 3 studies in ongoing stage across Diabetes (Insulin and Others), Obesity, Hypoglycemia, Diabetic Foot etc.
• Extensive network of over 107Endocrinology Sites and 150 Investigators including Leading KoLs, Private Clinics etc., access to a large patient pool for Type II Diabetes Mellitus for rapid patient enrolment

Illustrative Endocrinology Programs

Central Nervous System

Practice Highlights

Rising geriatric population all over the world and increased life expectancy is seeing the Central Nervous System (CNS) as one of the largest disease segments globally. Estimated at $ 53.1 Bn and growing at a CAGR of 4.7% (Source: GBI Research), there are currently 24,316 clinical trials running globally and 341 clinical trials running in India as per Clinicaltrials.gov. Karmic has worked on some highly advanced CNS programs and our CNS practice highlights are:

• Strong domain expertise with experience of 7 completed CNS Studies and 3 studies in ongoing stage across multiple Neurology and Psychiatry disorders including Ischemic Stroke, Depression, Parkinson’s Disease, Alzheimer’s Disease, Epilepsy, Head Injury etc.
• Extensive network of over 100 CNS Sites and 150 Investigators comprising institutional as well as private hospital set-ups on a Pan-India basis
• Strong experience with CNS Protocol Design& Validation, Subjective Scales, MRI/MRS data Collection and Analysis etc.

Illustrative CNS Programs

Immunology

Practice Highlights

As per BCC Research, the Immunology Diseases Marketwas a $ 72.2 Bn market in 2010 and as per Clinicaltrials.gov, as many as 16,951 trials are currently registered in immunology globally out of which 238 trials are happening in India. Karmic has strong experience in Immunology and Auto-Immune Diseases and the highlights of our Immunology practice are:

• Strong domain expertise with experience of 6 completed Immunology and Auto-Immune Studies and 3 studies in ongoing stage across multiple indications such as HIV, Rheumatoid Arthritis, Psoriasis, Ulcerative Colitis, Hepatitis etc.
• Extensive network of over 500+ Sites and Investigators focused on Immune Diseases, experience with Immunomodulators

Illustrative Immunology Programs

Ophthalmology

Practice Highlights

The Global Ophthalmic Drug and Devices market is pegged around $ 25 Bn and is expected to grow to $ $ 36 Bn by 2014 as per analysis by Markets and Markets. As many as 4914 Ophthalmology trials are happening worldwide and 102 studies are happening in India. Karmic has a robust Ophthalmology experience and highlights of the same are:

• Strong domain expertise with experience of 12+Ophthalmology Studies across indications such as Glaucoma, Acute Macular Degeneration, Diabetic Nephropathy, Dry Eye Disease and Cataract and 4 studies in ongoing stage
• Supporting several Phase IV and PMS programs for global Ophthalmic leaders across EU and APAC
• Extensive network of over 120+ Sites and Investigators focused on Ophthalmology including relationships with KoLs and reputed Ophthalmic Institutions, monitoring team with strong understanding of Ophthalmology procedures and instruments etc.

Illustrative Ophthalmology Programs

Other Therapeutic Areas

Besides the six key areas mentioned above, Karmic has strong experience across 8 other therapeutic areas and has supported several programs across multiple indications. See summarized details below, additional information can be furnished as per sponsor requirements:

Gastroenterology

Karmic has handled 6+ studies across multiple Gastroenterology indications including IBD, IBS, Ulcerative Collitis, Gastro-intestinal Tract Infections and Diahorrea and we have 600+ sites in our network.

Infectious Diseases

Karmic has handled studies across Infections such as LRTI, URTI, UTI, Influenza etc. and have experience with Gram +ve and Gram –ve strains across 4+ studies. Again we have over 500+ Internal Medicine and General Practitioner sites to run such studies.

Orthopedics & Pain Management

Karmic has handled 6+ clinical and medical devices studies across various Orthopedic indications such as Osteoarthritis, Inflammation and Pain related to Musculo-Skeletal Conditions, Rheumatoid Arthritis, Post Operative Pain, Dental Pain etc. and have access to 100+ Sites.

Respiratory

Karmic has handled 4 Asthma and COPD programs for Indian and Global pharmaceutical companies and have a network of 60+ sites to run respiratory programs.

Urology

Karmic has handled3 Urology Clinical and Medical Device programs across Stress Urinary Incontinence, Benign Prostrate Hyperplasia and Urinary Tract Infectionsand has access to 30+ Urologists.

Dermatology

Karmic has handled 5+ Dermatology programs on Acne Vulgaris, Genital Herpes, Vasoconstrictor studies for topical applications etc. and has access to 300+ dermatology sites including sites with state-of-the-art instruments including Spectrophotometers etc.

Gynecology

Karmic has handled 3 programs in Gynecology including Cervical Cancer, Breast Cancer and Contraceptive studies. Dr. Nitin Joshi, our Associate Director – Medical Affairs is an MD Gynecology and we have a network of 400+ gynecology sites and can support your program needs.

Pediatrics

Karmic has handled 2 Pediatric studies and Dr. Amita Birla, our Associate Director – Clinical Operations is a DCH with specialization in Pediatrics. We have access to 100+ pediatric sites and can support your program needs.

Non-Drug Areas

Medical Devices

Karmic has handled 11 Medical Device programs including Cardiac Stents, PTA Balloon Catheters, AV Shunts, Peripheral Shunts, Knee Prosthetics, SUI Slings, Gynecology Devices, Medication Reminder Devices, Neurological Devices etc. and has strong expertise in supporting the device design, prototyping, validation, regulatory approvals and trial conduct for the same.

Biologics / Biosimilars

Karmic has worked on several Biologics and Biosimilars including Interleukins, Darbepoetin, Erythropoetin, Filgrastin, Oprelvekin, Insulin / Oral Insulin, Peg Interferon, sVEGF Inhibitors and Mono-Clonal Antibodies and bring in deep scientific expertise in executing such programs.

Nutraceuticals

Karmic has managed 5+ Nutraceutical programs across products such as Flours, Oils, Dietary Supplements and can bring in deep expertise on trial design, patient diary management and data analysis aspects.