Services

At UpOwls, our Training, Inspection, and Audit Preparation services serve as a shield, ensuring your team is equipped to navigate regulatory inspections seamlessly. We offer tailored training programs that empower your personnel with in-depth knowledge of regulatory requirements and best practices. With a focus on proactive preparedness, our services instill confidence, fortifying your team to confidently face regulatory inspections and audits and mitigating potential risks.

• Protocol Review and Pharmacovigilance (PV) Activities: Ensuring subject safety through meticulous protocol assessment and PV operations.
• Adverse Event (AE) Collation, Review, and Reporting: Methodical compilation, scrutiny, and reporting of AEs.
• Periodic AE Reporting: Timely submission of consolidated AE reports at regular intervals.
• Safety Update Writing and Submission: Crafting and submitting safety updates to regulatory and ethical bodies.
• Expedited Reporting of SUSARs: Swift reporting of suspected unexpected serious adverse reactions.
• PV Section Writing and Review in Study Reports: Crafting and reviewing PV sections within comprehensive study reports.
• Seamless Drug Safety Approach: Holistic management of product safety in both clinical and post-marketing assessments

At UpOwls, we specialize in providing adaptable regulatory services tailored to each case, including:

• Regulatory Strategy Development: Crafting strategic approaches customized to your specific regulatory needs.
• Expertise in Clinical, Non-Clinical, and CMC: Proficiency across clinical, non-clinical, and Chemistry, Manufacturing, and Controls (CMC) domains.
• Preparation and Submission of CTAs/INDs for Phases I-IV: Assisting with the meticulous preparation and submission of Clinical Trial Applications (CTAs) or Investigational New Drug (IND) applications for all phases of trials.
• Regulatory Agency Liaison: Engaging in effective communication and preparation for meetings with regulatory agencies.
• Marketing Authorization Applications: Assisting in the preparation and submission of marketing authorization applications.
• Ethics Committee Submissions: Facilitating the submission process to ethics committees.

Our tailored approach ensures efficient and effective regulatory support, adapting to your unique requirements for successful regulatory compliance.

At UpOwls, we provide tailored executive consulting services and hands-on contracts utilizing the expertise of our PVRM team.

Our services encompass safety operations, data collection, triage, quality checks, causality assessment, and reporting to regulatory authorities. We ensure personalized attention to meet your specific needs.

At UpOwls, our Biostatistical Analysis services stand as the bedrock of informed decision-making in clinical research. We offer meticulous and sophisticated statistical analysis that translates complex data into actionable insights. Our seasoned team employs cutting-edge statistical methodologies to analyze and interpret clinical trial data with precision and rigor. From study design consulting to comprehensive analysis and interpretation, we ensure robust statistical strategies aligned with regulatory requirements. With a commitment to accuracy and innovation, our biostatistical expertise empowers confident decision-making, driving successful outcomes in clinical research and drug development.

At UpOwls, our Medical Writing services transform complex scientific data into clear, impactful narratives. With precision and proficiency, we communicate your research findings and clinical insights effectively, ensuring clarity and compliance with regulatory standards. Leveraging deep scientific expertise and linguistic finesse, our medical writers deliver documents that resonate with precision, enabling seamless communication across diverse stakeholders. With a commitment to accuracy and coherence, our medical writing services elevate the dissemination of critical scientific information in an effective manner, empowering impactful decision-making and successful research outcomes.

• Patient Eligibility Screening
• Management of Informed Consent Processes
• Monitoring and Reporting of Adverse Events
• Tracking Protocol Adherence and Compliance
• Assurance and Verification of Data Quality
• Ongoing Patient Follow-Up until Trial Completion
• Accountability and Management of Investigational Products
• Assessment of Serious Adverse Events (SAEs)
• Causality Assessment (ICSR)
• Training and Support for Site Staff
• Management of Study Protocol Amendments
• Review and Analysis of Clinical Data
• Laboratory Monitoring (Central or Local)
• Protocol Development and Amendments
• Collection and Documentation of Data