CLINICAL TRIALS

Raptim’s support systems and infrastructure enable us to provide the highest level of program management and clinical development services for Phase II-IV clinical trials. Our experienced clinical operations team has worked on Phase 1 to Phase 4 clinical studies and has project management expertise in niche therapeutic areas and indications.

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Raptim provides a comprehensive range of services in focused therapeutic areas like Oncology, Respiratory, Psychiatry, Gynecology, Dermatology, Orthopedic, Nephrology, Neurology, Ophthalmology, Cardiology, Gastroenterology, Infection, Endocrinology, etc. Raptim’s Clinical trial support team consists of highly experienced and qualified professionals. They have combined industry expertise of more than 100 years. We have access to >1200 GCP-trained investigators with experience to handling inspections by major regulatory agencies like USFDA and EMA.

Our Services

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Clinical Operations

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Project & Site Management

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Medical Affairs

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Regulatory

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Biostatistics

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Data Management

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Quality Assurance

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SUCCESSFULLY COMPLETED USFDA INSPECTION AT 9 MULTICENTRIC SITES

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Experience Highlights

Completed 25+ Clinical Trials for USFDA, Canada and DCGI
Phase II-IV Trials
PK studies and clinical end point studies
Post Marketing Surveillance (PMS) Studies
Recruited~ 3000 Patients
Various Therapeutic Indications
Real World Evidence (RWE) Studies

17 years of clinical research

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25+

Studies Conducted(All Phases)

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3000+

Patients Enrolled

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30+

Team Members & Growing

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9+

Investigator’s Sites Have Been Audited By USFDA & Received Approval

Clinical Trials Experience

Molecule Indication Study Type Submission No. of Subjects No of sites
Clindamycin Lotion Acne Vulgaris Phase III US FDA 915 11
Racemethionine 200 mg + Taurine 500 mg Tablets Alcohol liver disease Phase III DCGI 200 1
New Drug Atopic Dermatitis Phase III DCGI 200 12
NCE(MAB) Ovarian Cancer Phase II USFDA 88 14
Nitazoaxanide Diarrhea Phase III USFDA 325 15
Sulfadoxine/ Pyrimethamine) 500 mg / 25 mg Tablets Acute, uncomplicated P. falciparum malaria Phase II DCGI 92 1
Hydrocortisone suppositories Symptomatic Internal Hemorrhoids Phase II US FDA 37 7
Liposomal Amphotericin Fungal Infection Phase IV DCGI 250 10
Cephalexin Extended Release and Clavulanate Potassium Tablets URTI & Skin & Soft Tissue Infection Phase IV DCGI 230 12
Felbamate 600 mg Tablets Epilepsy PK Studies in Patients US FDA 38 4
Mecobalamin 100 mcg/0.2 mL Intramuscular Injection Vit B12 deficient Subjects PK Studies in Patients POC 18 1
Clozapine 100 mg Tablets Schizophrenia PK Studies in Patients Pilot study 12 1
Capecitabine Metastatic colorectal cancer, Locally advanced or metastatic breast cancer and Stage III (Duke’s stage C) colon cancer PK Studies in Patients DCGI 16 4
Pazopanib HCL Renal Cell Carcinoma(RCC) PK Studies in Patients US FDA 48 15
Sunitinib Malate Renal Cell Carcinoma(RCC), Gastrointestinal Stromal Tumor(GIST) PK Studies in Patients US FDA 42 11
Sunitinib Malate Renal Cell Carcinoma(RCC), Gastrointestinal Stromal Tumor(GIST) PK Studies in Patients US FDA 15 4
Felbamate Epilepsy PK Studies in Patients US FDA 39 5
Imatinib Mesylate Chronic myeloid leukemia and GIST PK Studies in Patients US FDA 39 5
Pegylated Liposomal Doxorubicin Hydrochloride Metastatic Breast Cancer/Advanced Ovarian Carcinoma PK Studies in Patients Canada 17 1
Formoterol and Budesonide Synchrobreathe COPD Real World Evidence(RWE) - 250 30
Bosentan Pulmonary Arterial Hypertension Real World Evidence(RWE) - 150 15
Budesonide Dry Powder Inhaler Rotacaps 400 mcg Mild to Moderate Asthma POC POC 20 1

*Working as a Rescue Partner for USFDA submission study


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