Lifesciences
Lifesciences, Pharmaceuticals and Biotech
Aeternus solutions life science, Pharmaceutical and Biotech division have years of experience with FDA, EMA, and other global regulatory agencies and can support you by navigating your projects to fruitful conclusion. Our expert consultants can support you at an individual task level, or manage your entire program in following areas:
Clinical Data Management
For any clinical study first-class, reliable and statistically thorough data is essential for clinical research; and an effective data management team is important to ensure accurate data collection from sites, perform data entry in electronic data capturing (EDC) systems, build/generate accurate reports and conduct study data validation. Our data management consulting group can collaborate with your clinical teams and understand the objectives and purpose of your research. They determinedly work to lessen non-critical data points through our well-designed data collection form.
Clinical Operations & Site Management
Our clinical operations consultants work closely with your team on protocol and indication training to kick-start clinical trials. They can support on identifying most suitable sites and build strong site relationships; they can obtain all relevant approvals required; provide round-the-clock support to the sites during study conduct and during study/site closeouts with the archive of all required study documents and be in compliance.
Bio statistics
For any clinical trials high-quality and accurate data analysis always stands as a critical component. Our expert PhDs consultants can develop the appropriate approach while documenting study Statistical Analysis Plan (SAP) and output shells. They can ensure employing strategies to improve your processes and oversight in presenting data, all in compliance with regulatory guidelines.
Medical writing and Publishing
Our experts can support writing and publishing of your regulatory reports by ensuring complete, compliant, and high-quality submissions. We can ensure that you receive the documents that have undergone rigorous statistical, scientific, quality control and editorial review, that are compliant with FDA, EMA, and all relevant global regulatory requirements.
Regulatory Affairs
Our Expert team can support on projects ranging from IND filing to NDA submissions and post-approval activities, and from intellectual property to FDA approval.
Quality and Compliance
Our consultants have specialization in implementing corrective and preventive action, we can develop solutions that address your quality and regulatory compliance processes. Protect your business and increase your efficiency by leveraging our strategy to manage systems implementations, process improvement, audits and remediation of problems.
Validation
Our expert team has extensive working knowledge on various validation projects in pharmaceuticals, biotechnology and medical device industries and can ensure that you meet and maintain compliance for worldwide regulations. Our expert team comprises of personnel’s that have computer system validation expertise for all types of FDA-regulated businesses and process and equipment validation.
Pharma covigilance/Drug-safety/ Clinical-safety
with expertise across multiple therapeutic areas, our safety staff are highly trained professionals (including MDs, PharmDs, and RNs) and are well versed in Case processing, Safety reporting, Signal monitoring and Risk management. Our flexible infrastructure allows towards custom solutions in specific to your product or studies.
Pharma covigilance (PV) audit & inspection compliance
Our PV compliance experts can conduct internal audits to identify gaps in your procedures that may expose you to regulatory risk. We can propose new procedures or modifications that will address any ‘hot spots.’ We can outline processes that are appropriate for the size and scope of your organization. If desired, we can help draft the procedures using your SOP template and format; we can assist in remediation activities resulting from audit observations.