Therapeutic Area

Neurology

CliniRx specializes in the field of neurological trials with a vast experience base. Multidisciplinary team at CliniRx understands the challenges faced such as longer study duration, complicated trial designs, vulnerable patient population, complicated patient scales, the extensive safety precautions and procedures required for the same, safety monitoring, and timely reporting of adverse events in neurology trials.

Highly experienced team can work on the regulatory, clinical operations, and monitoring services. With a network of highly experienced investigators CliniRx team works closely with both the sponsor team and investigators to ensure smooth trial operations.

The CliniRx Team has experience in the following Neurological Indications to name a few:

• Parkinson’s Disease,
• Ataxia Telangiectasia,
• Traumatic Brain Injury,
• Rett Syndrome

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Psychiatry

CliniRx has sizeable experience in conducting psychiatry studies with New Chemical Entities for Phase II, Phase III, with various indications. The team consists of In-house MDs (Psychiatrists), regulatory and operational experts who have planned, designed, and successfully conducted large Phase -II and III programs, globally.

Salient features:

• Complexity: Conducting studies in this population becomes complex due to the involvement of caregivers, raters, scales, study drug adherence, etc.
• Speed: Although complex, CliniRx has demonstrated quick enrolment into the study due to flat operating structure and a small built team of multi-disciplined personnel accelerate the contracting and sitestar-tup.
• Site and investigator relationships: Highly experienced teams (PIs, Raters, coordinators) at the sites, with strong relationships, allows quick turn around the feasibility(ies), accelerate enrolment, and move trials forward, in order to provide high-quality data.
• Regulatory engagement: Knowledgeable in the changing regulatory landscape at local, regional, and global levels, CliniRx team can provide regulatory support and strategy.

CliniRx’s clinical trial experience includes but is not limited to the following indications:

• Chronic Schizophrenia,
• Treatment-Resistant Schizophrenia,
• Bi-Polar Disorder

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Oncology

With a highly experienced and well-trained team, CliniRx is in a position to support Sponsor in achieving the success in delivering new medical advances. From liaising with regulatory authorities, selecting the right sites, and optimizing patient enrolment, vastly experienced CliniRx team will ensure that the study is planned carefully and executed seamlessly.

CliniRx recognizes the significance of the relationship with investigative sites to ensure successful patient recruitment & retention and work as partners with both sponsor and investigators to ensure optimal trial operations.

CliniRx offers extensive experience in following indications but not limited to:

• Breast Cancer,
• Non-small cell Lung Cancer,
• Hormone Resistant Prostate Cancer,
• Castration-Resistant Prostate Cancer,
• Non-Hodgkin’s Lymphoma

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Ophthalmology

CliniRx team is well-trained, experienced, knowledgeable, and specialized to manage local and global clinical trials in the field of Ophthalmology. CliniRx is well experienced to manage clinical trials of ophthalmic drug, device, or biologicals through our end-to-end clinical trial capabilities.

CliniRx team is capable to understand the risks and challenges and strategizes accordingly to maximize quality, productivity, and value for an ophthalmology clinical trial. CliniRx’s highly experienced regulatory, operations, and medical team works closely with Sponsor’s teams right from study design to commercialization and beyond.

CliniRx team is well placed to overcome Ophthalmology clinical trials (inherent challenges) like rare nature of some diseases, complex study design involving masked and unmasked teams, narrow inclusion and exclusion criteria especially in case of posterior uveitis and wet AMD studies, specialized study procedures, tapering of study medication, study medication administration, rescue criteria and medication, study questionnaires, central reading, patient recruitment, and retention, and specialized technicians.

CliniRx’s clinical trial experience include but is not limited to the following Ophthalmology Indications:

• Uveitis,
• Conjunctivitis,
• Glaucoma,
• Dry Eye,
• Macular Edema,
• Age-related Macular Degeneration,
• Retinal Vein Occlusion,
• Lens opacification/post-cataract surgical inflammation

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Cardiovascular and Metabolic Diseases

Cardiovascular and metabolic disease clinical trial expertise, immense experience, and highly trained resources give CliniRx not only a competitive advantage but also makes us the right CRO for any cardiovascular and metabolic disease clinical trials.

Focused Project Management team is committed to deliver and meet expectations in terms of quality, cost, and timelines. Be it drug, device, or biologicals clinical trials, CliniRx can provide the best, timely, risk-based solutions as we understand that cardiovascular and metabolic disease clinical trials pose challenges such as complex study design, composite endpoints, regulatory uncertainties, late-stage failures, mega and long duration studies, patient recruitment and retention, extensive study procedures, high-risk study population, extensive monitoring and safety reporting, high-risk classification of cardiovascular devices (due to their structural complexity, multiple components design, and even diverse intricate functional interfaces) as they are more prone to failures, thus eventually having a strong impact on their safety and performance and rising cost.

CliniRx’s clinical trial experience includes but is not limited to the following cardiovascular and metabolic diseases:

• Critical Limb Ischemia,
• Hypertension,
• Type 2 Diabetes,
• Arrhythmias,
• CVD

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Infectious Disease

CliniRx has a team having high experience with infectious diseases. The team comprises of medical, regulatory, and operational experts who have extensive experience designing and conducting infectious disease clinical trials.

Salient features of infectious disease clinical trials:

• Speed: Flat operating structure and a small built team of multi-disciplined personnel allows greater efficiency, brisk moving, accelerate contracting and site-start-up.
• Site and investigator relationships: Strong relationships with sites allow quick turn around the feasibility(ies), accelerate enrollment, and move trials forward.
• Regulatory engagement: Knowledgeable in the changing regulatory landscape at local, regional, and global levels. Our team can provide regulatory support and strategy.

CliniRx’s clinical trial experience includes but is not limited to the following anti-infective indications:

• Bacterial Infections,
• Complicated Skin Infections,
• Fungal Infections,
• Herpes zoster,
• Skin & Soft Tissue Infections

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Gastroenterology & Hepatology

CliniRx’s therapeutically aligned project team will work in coordination with multi-functional teams, providing medical, regulatory, and operational expertise required for the Gastroenterology and Hepatology Clinical Trials to circumvent major challenges such as:

• Rigorous regulatory requirements for all phases of drug development.
• Exploding trial activity leading to competition for subjects.
• Long-duration studies leading to subject retention challenges.
• Use of placebo and its substantial response rates in studies with psoriasis, rheumatoid arthritis, and ulcerative colitis trials.
• Challenges associated with the use of patient-reported outcomes, and logistic challenges faced by the multicounty travelers’ diarrhea trials.

Our clinical trial experience includes but not limited to the following gastroenterology and Hepatology indications:

• Travelers’ Diarrhoea,
• Pediatric Diarrhoea,
• Pediatric Constipation,
• Chronic Kidney Disease

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Respiratory

Clinical studies in the respiratory therapeutic area has many unique challenges such as patient symptom diaries, exacerbation capture, reversibility testing, extensive run-in treatment periods, repeated serial spirometry, home-based PEF monitoring, large subject recruitment requirements. This is why, an experienced team at CliniRx is well placed to handle the project plan, with a focus on delivering within budget and that too on time.

CliniRx has experience in the following indications, but not limited to:

• Asthma (mild to severe – drug and medical device),
• COPD,
• Lung Cancer,
• Upper and Lower Respiratory Tract Infections

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