Innovation Simplified. Precision Amplified.
Over 15 years of experience in biomedical research, technology development, and project execution across disciplines.
Decoding Challenges, Delivering Precision
At Etanios Research, we believe that simplicity, precision, and clarity—core principles of Morse code—are essential for solving complex challenges in today’s biotech, pharmaceutical, and nutraceutical industries. Just as Morse code transformed global communication by converting complexity into clear signals, we help organizations decode intricate scientific and business problems into actionable solutions.
With expertise in preclinical drug development, technology development, real-world evidence, nonclinical strategies, oncology, inflammation research, and innovative services like market landscape analysis, IT solutions, and scientific writing, Etanios Research is your trusted partner for delivering success.
Nonclinical Development Strategies
The transition from preclinical to clinical phases is a critical step in drug development. Our nonclinical development strategies bridge this gap effectively, ensuring a smooth progression through regulatory milestones.
Our Services Include:
Market and Competitor Landscape Evaluation:
Identifying opportunities and challenges in your therapeutic area.
Conducting a detailed analysis of competing products and strategies to position your development plan effectively.
Providing actionable insights to differentiate your product in the market.
Optimal Clinical Indications:
Defining and refining target product profiles.
Aligning nonclinical strategies with intended clinical indications and patient populations.
Evaluating unmet medical needs to identify the most promising therapeutic applications.
Study Design and Data Interpretation:
Designing tailored nonclinical studies to meet regulatory and clinical needs.
Analyzing and interpreting data to ensure robust scientific support for regulatory submissions.
Preparing comprehensive reports and presentations to communicate findings effectively.
GXP Documentation:
Development and review of key documentation, including protocols, reports, training materials, and master plans.
Ensuring compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and other relevant standards.
By addressing every aspect of nonclinical strategy, we ensure that your program is scientifically rigorous, strategically sound, and ready for regulatory scrutiny.
Preclinical Drug Development
Developing a robust and strategically planned preclinical data package is essential for the success of drug discovery and regulatory approval. Failure to execute an effective preclinical development program can lead to delays or application failures. At Etanios Research, we offer expert preclinical consulting services designed to optimize your drug discovery and development process, saving time and cost while ensuring high-quality outcomes.
Key Features of Our Preclinical Drug Development Services:
Comprehensive Literature Review:
Conducting extensive, topic-specific searches.
Analyzing and synthesizing relevant scientific data to inform strategic decisions.
Providing clients with a detailed report summarizing findings and recommendations.
Strategic Preclinical Development Plans:
Tailored strategies addressing both safety and efficacy requirements.
Ensuring alignment with regulatory guidelines and clinical objectives.
Incorporating best practices for data generation, validation, and presentation.
Study Design and Oversight:
Creating bespoke experimental models that reflect the intended clinical population.
Defining and supervising safety and efficacy endpoints.
Providing hands-on oversight during study execution, including data analysis and troubleshooting issues that arise during experimentation.
Gap Analysis and Roadmapping:
Evaluating existing preclinical data packages to identify deficiencies.
Developing a comprehensive roadmap to fill gaps and fortify regulatory submissions.
Ensuring that all components of the preclinical package are scientifically sound and regulatory-compliant.
Our extensive expertise spans over 15 years in therapeutic areas such as inflammation, pain, anti-infectives, medical devices, and nutraceuticals. From early drug discovery to advanced preclinical development, we provide customized solutions tailored to your unique needs. Our collaborative approach ensures that each project benefits from personalized attention and a commitment to excellence.
Clear and accurate scientific communication is vital to advancing research and securing regulatory approvals. Etanios Research offers professional scientific writing services, ensuring precision and clarity in your documentation.
Our Writing Services Include:
Manuscripts for peer-reviewed journals.
Grant proposals and funding applications.
Preclinical pharmacology study protocols and reports.
Integrated Summaries of Efficacy (ISE) and Safety (ISS).
New Drug Applications (NDAs).
Investigator Brochures (IBs).
Literature reviews and interim data summaries.
Product development plans.
Our Deliverables:
Designing figures and tables to enhance data visualization.
Formatting bibliographies to meet journal and regulatory requirements.
Conducting scientific reviews to ensure accuracy and compliance with industry standards.
From concept to submission, our team provides comprehensive support, helping you present your research and findings effectively to a global audience.
Scientific Writing
Leverage our network of trusted Contract Research Organizations (CROs) and vendors to achieve seamless project execution. Our team handles all aspects of CRO collaboration, from project planning to study execution.
Services Include:
Detailed Project Planning and Management:
Developing comprehensive timelines and budgets.
Identifying and mitigating risks to ensure project success.
Mediation and Negotiation with CROs:
Facilitating communication and alignment between all stakeholders.
Ensuring that study protocols are clearly understood and implemented.
Oversight of Outsourced Studies:
Monitoring study progress to ensure adherence to timelines and quality standards.
Providing interim analyses and actionable feedback to optimize outcomes.
By integrating our expertise with the capabilities of our CRO partners, we deliver cost-effective and efficient solutions tailored to your project requirements.
Colloborating & CRO Management
Training & Courses
Knowledge drives success. Etanios Research offers tailored training programs and courses to upskill teams and ensure they stay ahead in a rapidly evolving research landscape.
Key Features of Our Training Programs:
On-site or virtual delivery to suit your operational needs.
Customized content aligned with your organizational objectives.
Hands-on learning with case studies, practical examples, and interactive sessions.
Post-training support and resources to reinforce learning.
Preclinical research design and execution
Risk assessment and regulatory strategies
Data analysis and interpretation for real-world evidence
Innovations in oncology and inflammation research
Scientific writing and communication skills
Etanios Research Offers Expertise in:
Biological Evaluation Plans (BEP) and Reports (BER):
Developing evaluation strategies compliant with ISO 10993 and ISO 14971.
Outlining a clear process for assessing the biological safety of devices.
Advanced In Silico Assessments:
Utilizing QSAR modeling and analogous read-across techniques for data-poor substances.
Employing commercial tools such as Lhasa and Leadscope for toxicological evaluations.
Supporting compliance with ICH M7 for genotoxicity evaluations and other relevant guidelines.
Biocompatibility Testing Plans:
Developing strategies following 3R principles to minimize animal testing.
Collaborating with Contract Research Organizations (CROs) for study execution and oversight.
Interpreting results and compiling comprehensive biocompatibility reports.
Whether you are evaluating the feasibility of a new device or ensuring compliance with stringent regulations, we provide the expertise and support you need to succeed.
Medical Device and IT Solutions
In today’s research environment, technology and innovation are critical for success. Etanios Research provides cutting-edge medical device consulting and IT solutions tailored to optimize workflows, support development, and ensure compliance.
Our Services Include:
Preclinical testing and evaluation of medical devices
Regulatory support and risk assessment
Data management systems for research operations
Workflow optimization through IT-driven solutions
By streamlining processes and integrating technology, we ensure precision, efficiency, and success in medical device and research management.
Nutraceutical Research Consulting
Nutraceuticals are increasingly recognized for their potential in preventive and therapeutic healthcare. At Etanios Research, we provide specialized consulting for nutraceutical product development, preclinical efficacy studies, and market positioning strategies.
Nutraceutical Services Include:
Study design for safety and efficacy testing
Scientific validation and documentation
Regulatory strategy and market entry analysis
Data-Driven Insights with Real-World Evidence
In a rapidly evolving landscape, real-world evidence (RWE) is key to understanding treatment outcomes and improving decision-making. Etanios Research supports clients in leveraging real-world data to evaluate product performance, safety, and market fit. Our expertise enables organizations to generate actionable insights for stakeholders, regulators, and patients.
RWE Services Include:
Real-world data analysis for oncology and inflammation therapies
Outcomes research to support product value and market access
Evidence synthesis and reporting for regulatory submissions
Market and Competitor Landscape Analysis
Understanding the competitive environment is essential for success. Etanios Research conducts comprehensive market and competitor landscape analyses to provide clients with strategic intelligence. By evaluating trends, competitors, and opportunities, we equip organizations to position their innovations effectively and maximize market impact.
Our Analysis Covers:
Competitor benchmarking in oncology, inflammation, and nutraceuticals
Emerging trends in therapeutic areas and technologies
Market assessments for new product development and launch strategies
Etanios Research LLC provided exceptional guidance in our cancer immunology project. Highly recommend their expertise!
John Doe
Their experience in biotechnology and IT projects significantly advanced our research outcomes. Truly invaluable consultancy services.
Jane Smith
