Request for Proposal
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Submit NowTherapeutic Expertise
Rare Disease
We have good experience in conducting rare disease clinical trials across multiple therapeutic areas, with a strong network of sites, regulatory expertise, and patient engagement strategies to ensure the success of studies in these complex indications.
Experience
- Primary Sclerosing Cholangitis (PSC): Experience in managing trials for this chronic liver disease with complex endpoints.
- Primary Biliary Cholangitis (PBC): Expertise in designing trials targeting bile duct inflammation and fibrosis.
- Nonalcoholic Steatohepatitis (NASH): Conducted clinical trials for novel therapies targeting inflammation and fibrosis.
- Sjogren's Syndrome: Experience in ophthalmic endpoints for autoimmune-related dry eye disease.
- Retinoblastoma: Expertise in designing pediatric oncology trials for this rare eye cancer.
- Glioblastoma - Experience conducting trials for aggressive brain tumors, including novel therapies and combination treatments.
- Renal Cell Carcinoma (RCC) - Experience with targeted therapies and immunotherapy trials.
- Established relationships with leading clinical research sites, academic institutions, and key opinion leaders (KOLs).
- Ability to activate sites quickly, ensuring faster trial initiation and patient enrollment.
- Global reach with sites across the United States and India, offering diverse patient populations for rare disease studies.
- Collaborations with patient advocacy organizations to enhance recruitment and retention
- Access to rare disease patient registries to identify eligible participants
- Community outreach programs to educate and engage rare disease patients
- Strong knowledge of FDA, EMA, and CDSCO rare disease regulatory pathways.
- Support for expanded access and compassionate use programs
- Clinical trial design & feasibility assessment tailored for small patient populations
- Biomarker-driven approaches to optimize study outcomes
- Remote monitoring solutions for patient convenience
