Clinical trials require a deep understanding of developing complicated processes and interpreting variables. ClinActis helps you navigate the clinical trial process, reducing time to market and minimizing costs. Our clients benefit from ClinActis’ years of experience working in leading pharmaceutical, in biotechnology companies, and working with ICH, GCP, FDA and other governing agencies.
We consider key components of the protocol and understand how they will shape the requirements for executing the trial. This enables us to provide the appropriate strategy required for each protocol considering its ease of execution, ability to deliver the science, and its impact on site operations. This understanding and knowledge of trial execution ensure an efficient process and guarantee that your project is finished on-time and within budget.
Clinical Regulatory Support
Clinical regulatory experts serve as resources to create protocols that can be completed efficiently and supported by sites. ClinActis provides support for Investigational New Drugs (IND) and New Drug Applications (NDA), guiding the client through each step of the process. We provide expert advices, attend planning meetings, prepare pre-meeting briefing packages, and facilitate communication with regulatory agencies.
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 Experience and Process
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:
Regulatory Authority Meeting Briefing Packages
NDAs/BLAs/MAAs (including 505(b)(1), 505(b)(2), 351(a), and 351(k) applications)
Orphan Designation Applications
Fast Track Designation Applications