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.
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 a combined industry expertise of more than 100 years. We have access to >1200 GCP-trained investigators with experience of handling inspection by major regulatory agencies like USFDA and EMA.
- PK and early phase-Patient based studies
- Phase II-IV studies
- PD-BE studies
- Clinical End Point (CEP) studies
- Post marketing surveillance (PMS) studies
- Investigator Initiated and real world evidence based studies
- Investigator and site selection
- Site initiation and management
- Project management
- Study monitoring
- Regulatory services
- Statistical analysis and report preparation
- Safety reporting
- Audit and compliance
- Data management
Most topical generic drugs require Bioequivalence assessment using Clinical End Point studies with a study design that includes three arms (Reference: Test: Placebo-Vehicle) for treatment of an approved indication in patient’s population. These studies are necessary to demonstrate Therapeutic Equivalence with the reference product and superiority with placebo.
Guidance from the USFDA has proven the importance of PK studies for determining drug concentration-time profiles in patient population. Based on available data we can decide whether healthy volunteers or patients should be recruited for a particular study. This is supported by available scientific information for collecting Pharmacokinetic (PK) data from a patient rather healthy subject. In addition patient based PK studies are conducted to test a drug already in the early development phase, when the adverse event profile of the substance and/or its metabolites carries too serious a safety/efficacy risk.
- Patients with renal insufficiency
- Patients with hepatic insufficiency
- Critically ill patients (Oncology)
- Poor versus extensive metabolizers
- Pediatric and Elderly populations
- Schizophrenic or bipolar disorder patients
- Epileptic patients
- Raptim’s experienced team has experience in handling clinical end point studies with cost efficient solution
- Extensive study support to overcome challenges to achieve the objective and regulatory support
- Statistical and medical writing capabilities for study designing attributes and sample size requirements
- Experience in Randomization technique to ensure blinding across selected sites
- Excellent Regulatory liaison
- Database with experienced investigator/Dermatologist to achieve faster recruitment