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CONSULTING SERVICES

Consulting Services

Experience Matters

At ClinActis, we understand the complexities involved in developing and interpreting variables in clinical trials. That's why we offer our expertise as an ad-hoc service to help you navigate the clinical trial process, reducing time to market and minimizing costs. With years of experience working with leading pharmaceutical and biotechnology companies, regional and global CROs, as well as governing agencies such as ICH, GCP, and FDA, our team is well-equipped to provide valuable insights and support throughout the entire clinical trial process. ClinActis can help you achieve success in your APAC clinical trial endeavors.

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Protocol Design

We understand the critical components of a protocol and how they shape the requirements for executing a successful trial. The ClinActis team is dedicated to providing the appropriate strategy for each protocol, taking into consideration ease of execution, ability to deliver on scientific objectives, and impact on local site operations across the APAC region. With our knowledge and expertise in trial execution, we ensure an efficient process and guarantee that your project is completed on-time and within budget. Trust us to help you achieve your clinical trial goals with confidence.

Clinical Regulatory Support

At ClinActis, our team of clinical regulatory experts can serve as a valuable resource in the clinical trial protocol writing process, ensuring the protocol can be completed efficiently and easily supported by sites. We provide comprehensive support for Investigational New Drugs (IND) and New Drug Applications (NDA), guiding our clients through each step of the regulatory process. Our expertise includes providing expert advice, attending planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies. Trust us to help you navigate the complex regulatory landscape with confidence and achieve successful outcomes for your IND or NDA.

Statistical Support

ClinActis employs highly qualified professionals who can analyze existing protocols for weakness and scientists who develop simulations and conduct ad-hoc analyses to investigate underlying assumptions or study results. We then package our results as responses to regulators' questions for our clients.

Broad Range of Regulatory Submissions Support

Each deliverable from ClinActis reflects the collaboration of our interdisciplinary team of Regulatory Affairs, Clinical Operations, Data Standards, Regulatory and Medical Writing, Project Management, Clinical Data Management, Biostatistics, and Programming staff. From early-phase development through life cycle management, we use a standardized library of document templates, data tools and programs, and processes to produce compliant regulatory submission documentation, reports, and dossiers. We ensure that the quality that drives all of our services is reflected in all of our submissions to regulatory authorities such as FDA and EMA.

Regulatory Submissions

ClinActis’ regulatory team is built with experienced professionals in clinical research, product development, data standards, quality assurance, and regulatory affairs. We can support many kinds of regulatory authority submission deliverables, including:

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  • INDs/CTAs/IMPDs

  • Regulatory Authority Meeting Briefing Packages

  • NDAs/BLAs/MAAs (including 505(b)(1), 505(b)(2), 351(a), and 351(k) applications)

  • Annual Reports/DSURs/PSURs

  • PIPs

  • Orphan Designation Applications

  • Fast Track Designation Applications

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