Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

Whether you are at the beginning of your development program and need to prepare your regulatory strategy, are meeting with the agency preparing to file your IND/CTA, are entering your pivotal Phase 3 studies and need to have a discussion with the regulatory agency, or are preparing to submit a marketing application – our regulatory experts can help. Our teams have prepared over 30 marketing applications (NDAs, MAAs, jNDAs, NDSs, etc.) to date, of which over 10 have received regulatory approval so far.

Advancing a novel therapy through clinical development is complicated.

Not all therapies make it to the patients that need them, not because they did not work, but because the design, data collection and/or analysis were not done right. Correctly designing, collecting, analyzing, standardizing, and reporting your clinical trial data to local and global regulatory agencies is critical to your success. To give you an advantage, Ethno Clinpharma has assembled an extraordinary team of scientific-minded biostatisticians, programmers, data managers and data standards experts, the power of industry-leading technology platforms and expertise in adaptive designs, to help you understand your data to make critical clinical development decisions.

Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today.

Our clinical data managers provide you with the optimal solution for your clinical trial that will allow your study to go from first patient in to database lock as quickly and efficiently as possible without compromising data quality or integrity.  We are a one-stop-shop for all data management activities from database build, through data cleaning and query resolution, to database lock and archival. Our team members are focused on developing partnerships routed in quality, efficiency, and transparency. The end result: cost-efficient data management; faster time to database go-live; a functioning, intuitive clinical database; expedited database lock; and ultimately, accurate and clean clinical trial data.

Explore Our Clinical Data Management Services

• Consulting (strategic program planning, protocol review, EDC selection, etc.)
• Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
• Database design, development, and maintenance
• Data validation programming and testing, inclusive of edit check and manual review specifications
• Data entry, if applicable
• Data cleaning and query management
• Medical coding using WHODrug & MedDRA dictionaries
• Serious adverse event (SAE) reconciliation
• Management and integration of local laboratory reference ranges with CRF data
• Integration, verification and reconciliation of external electronic data
• EDC selection and end-user training
• Database lock and archival
• Database transfer

Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout the entire clinical development process. Biostatistics is at the heart of every clinical study—driving study design, study conduct, data collection, analysis and reporting—and our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis.

Our Statistical Experience

We have extensive experience providing biostatistical consulting  and services from study design and protocol development to study analysis through regulatory submission and agency meeting representation.  Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.

Engage our biostatisticians to support the planning and biostatistical analysis of your clinical trial and regulatory submissions projects.  Or, partner with us to make our biostatistical team your team.

Explore Our Biostatistic Services

• Study design  
• Protocol development
• Strategic statistical consulting
• Sample size calculations
• Endpoint development
• Randomization schemes
• Statistical analysis plans (SAP)
• Statistical tables, data listings, and figures for clinical study reports (CSRs)
• eCRF design and review
• Statistical analyses and reports
• Pharmacokinetic and pharmacodynamic analyses
• Regulatory Submissions – Regulatory guidance, planning, and meeting representation
• Integrated safety and efficacy analyses (ISS/ISE/ISM)
• Data Monitoring Committee (DMC) services
• SDTM and ADaM dataset preparation (submission ready dataset packages)

Ethno Clinpharm supports successful pre-approval and post-market pharmacovigilance (PV) and Medical Information (MI) expertise for pharmaceutical drugs (brand and generic), biologics, radiopharmaceutical drugs, natural health products, and medical devices.

our experienced experts deliver pharmacovigilance services at all levels, including specialists, senior consultants, strategists, and safety physicians.

Safety Surveillance Requires the Right PV System

Pharmacovigilance systems and processes impact every element of the product life cycle from development to post-marketing therapeutic/product development. Drug developers and marketing authorization holders should maintain quality pharmacovigilance systems and processes that meet the regulatory requirements and monitor ongoing product safety. Additionally, the systems must detect any changes in an investigational or approved product’s risk-benefit balance.

At Ethno Clinpharm, our team of Pharmacovigilance experts understands the challenges with the set-up and maintenance of proper safety surveillance. 

       Expert Guidance for PV System Implementation

Every therapeutic product developer and marketing authorization holder must understand and follow the pharmacovigilance regulatory requirements to ensure drug safety. Our experience PV experts and trainers help clients to:

• Audit and make recommendations to improve an existing PV system
• Implement and validate a new PV system
• Develop and validate Standard Operating Procedures (SOPs)
• Provide initial ongoing PV Training for all staff
• Broker PV Agreements with partners and vendors
• Ensure that the PV system is inspection ready

Audits & Regulatory Agency Inspections

Regulatory agencies (including FDA, Health Canada, MHRA, and EMA) can conduct an inspection at any time in your product’s life cycle. They might inspect you during your clinical trial, during the regulatory review/approval process, or after your product is on the market.

That is why we recommend that you always be inspection-ready.  Plan and perform mock or self-inspections, conduct a thorough gap analysis before the regulatory agencies show up.   If you do not have the time, knowledge, or resources to prepare for and navigate an agency inspection, we can help.