Clinical Development

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CLINICAL

DEVELOPMENT

  1. Strategic Planning: RP sets its strategic direction for clinical development, identifying therapeutic areas or specific drug candidates where there is a need for further clinical investigation. This could be based on preclinical data, market analysis, patient needs, or scientific advancements.
  1. Clinical Trial Design: Our team of clinical experts, including clinical scientists, medical advisors, and statisticians, design clinical trial protocols outlining the objectives, patient population, treatment regimens, endpoints, and other key parameters for each trial.
  1. Contract Research Organizations (CROs): We outsource to CROs for managing various aspects of clinical trial operations, including patient recruitment, site selection, data collection, monitoring, and regulatory compliance.
  1. Vendor Management: We oversee and coordinate the activities of multiple CROs and other vendors involved in clinical trial execution. This includes selecting the appropriate vendors, negotiating contracts, and ensuring that all parties adhere to timelines, budget constraints, and quality standards.
  1. Regulatory Affairs: Our regulatory affairs team ensures that clinical trials comply with regulatory requirements in each target market. They prepare and submit clinical trial applications to regulatory authorities, respond to regulatory inquiries, and maintain documentation to support regulatory submissions.
  1. Safety Monitoring: We establish systems for monitoring the safety of participants enrolled in clinical trials. This includes collecting and analyzing adverse event data, implementing safety protocols, and reporting safety findings to regulatory authorities and ethics committees.
  1. Data Management and Analysis: Data management professionals oversee the collection, cleaning, and analysis of clinical trial data to ensure its quality, integrity, and compliance with regulatory standards. Statistical analysts analyze trial results to evaluate the safety and efficacy of the investigational product.
  1. Clinical Development Plans: Based on the results of clinical trials, we develop clinical development plans outlining the next steps for advancing the product through additional trials, regulatory submissions, and eventual commercialization.
  1. Scientific and Medical Communication: Our medical affairs team disseminates clinical trial findings through scientific publications, conference presentations, and interactions with key opinion leaders to support the scientific and medical understanding of the product.
  1. Commercialization Strategy: As clinical development progresses, we formulate a commercialization strategy for the product, which may involve building internal commercial capabilities, partnering with other companies for marketing and distribution, or pursuing licensing agreements.
In summary, Remik Pharma specializes in clinical development manages and oversees the execution of clinical trials through strategic partnerships with CROs and other service providers, leveraging external expertise and resources to advance its pharmaceutical products through the development pipeline