Clinical Consulting Services

Clinical Affairs Services

• Clinical Development Services and Planning: We work closely with our clients to identify key milestones, develop timelines, and optimize resources to maximize the success of their clinical programs.
• Clinical Trial Consulting, Design, and Protocol Development: From protocol development to statistical analysis planning, our team provides valuable insights and guidance to ensure the success of our clients' clinical research initiatives.
• Medical Writing Services: Our team of skilled medical writers offers a range of documentation services, including the preparation of clinical trial protocols, investigator brochures, regulatory submissions, and scientific manuscripts.
• Due Diligence Assessment and Gap Analysis: We conduct comprehensive due diligence assessments and gap analyses to evaluate the robustness of our clients' clinical development programs and identify areas for improvement.
• Interfacing with Industry Experts and Regulatory Authorities: We provide strategic guidance and support in navigating regulatory requirements, fostering partnerships, and addressing complex regulatory challenges.

Clinical Operations Services

• Clinical Trial Management and Monitoring: We offer end-to-end support in study planning, site selection, patient recruitment, data collection, and quality assurance.
• Clinical Research Organization and Vendor Qualification and Management: We assist clients in selecting and managing clinical research organizations (CROs) and vendors to support their clinical trials.
• Trial Master File Creation and Maintenance: We provide guidance on document management best practices, quality control processes, and inspection readiness.
• Clinical Quality Compliance Audits: We conduct clinical quality compliance audits, including Good Clinical Practices (GCP) and pharmacovigilance (PV) audits, to assess the quality, integrity, and regulatory compliance of our clients' clinical trial activities.
• Standard Operating Procedure (SOP) Development: We offer customized SOP development services to assist clients in establishing standardized procedures, workflows, and guidelines for their clinical trial operations.
• Others: We also provide support for training program development and project management.

Our team has a deep understanding of the pharmaceutical industry, allowing us to provide expert guidance and support to our clients.

We take a customized approach to each client engagement, ensuring that our services are tailored to meet the specific needs of our clients.

We are committed to providing high-quality services that meet the highest standards of excellence in clinical consulting.

We work closely with our clients to understand their unique challenges and develop solutions that meet their specific needs.