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PRODUCTS AND SERVICES
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![Lab of the Future GettyImages-1449925917]( "Novotech Laboratory Services")
Our bioanalytical services assist our customers in every stage of their molecule development.
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![two-business-people-GettyImages-1354841430]( "Clinical Operations And Project Management For Every Phase")
Get streamlined and integrated clinical trial services delivered by a dedicated team of professionals with deep industry and therapeutic area expertise across all phases of clinical development.
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![GettyImages-1180547354 clinical trial tablet research]( "Full Service CRO And Regulatory Partner For Biologics")
Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.
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![doctor ipad iStock-1189303763.jpg]( "Clinical Operations")
inSeption’s Clinical Operations and Project Management subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.
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![5 (Fairly Simple) Statistical Analysis Plan Elements To Implement In Your Clinical Study]( "Biostatistics & Statistical Programming")
Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services and statistical reports are customized and designed specifically to meet your project requirements.
WHITE PAPERS AND CASE STUDIES
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![GettyImages-1325053945-lab-team-collaboration]( "Supporting A Sponsor From SPA Rejection To BLA Submission")
Supporting A Sponsor From SPA Rejection To BLA SubmissionLearn how the clinical trial design and the statistical foundation of the special protocol assessment (SPA), which helped drive to regulatory agreement, was transformed in this case study.
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![Diversity-GettyImages-1450298872]( "Patient Diversity: Identifying Challenges, Opportunities, And Best Practices")
Patient Diversity: Identifying Challenges, Opportunities, And Best PracticesBy listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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![coronavirus covid-GettyImages-1220020527]( "Expert Consulting And MRCT Strategy Rescues Oncology Program")
Expert Consulting And MRCT Strategy Rescues Oncology ProgramUncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.
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![GettyImages-1305685152 vaccine]( "Advancing From Single Country Phase 1 Success To Multinational Phase 1/2 Trial")
Advancing From Single Country Phase 1 Success To Multinational Phase 1/2 TrialExplore how this partnership aims to contribute to the success of the trial by leveraging global resources and streamlining processes for efficient and timely results.
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![GettyImages-1201227832 data]( "A Comprehensive Planning Approach For Cancer Antibody")
A Comprehensive Planning Approach For Cancer AntibodyDiscover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase I protocol for an immuno-oncology antibody.
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![GettyImages-1156352527 sites]( "Site Perspectives On Decentralized Clinical Trials")
Site Perspectives On Decentralized Clinical TrialsDiscover why understanding clinical research sites’ experiences and perspectives on DCTs will help industry stakeholders refine trial design, operational procedures, and regulatory policy to better serve patients and sites.
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![GettyImages-1199010148-cost-analysis-financial-reporting-finance-graph]( "Leading CRO Selects LifeSphere Safety Document Distribution")
Leading CRO Selects LifeSphere Safety Document DistributionIn this case study, gain insight into how a large CRO overcame the struggle to meet the service requirements of clients in a cost-effective and efficient way.
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![GettyImages-1293773576-lab-team-collaboration-planning-research]( "Overcoming Inventory Challenges For A Complex, Global Study")
Overcoming Inventory Challenges For A Complex, Global StudyExplore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.
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![GettyImages-1342134434 patient]( "Optimizing Your Clinical To Commercial Journey")
Optimizing Your Clinical To Commercial JourneyHow should you think about optimizing the journey from the development stage of clinical trials to commercialization? Review considerations to eliminate avoidable delays and have a seamless transition.
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![GettyImages-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Moving CGTx Clinical Development Forward In 2023Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
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![iStock-1211951067-distribution-global-network]( "To Future-Proof The Pharma Supply Chain, Digitize")
To Future-Proof The Pharma Supply Chain, DigitizeThe demand for pharma products is growing — can the industry keep up? Explore three ways digitization can help pharmaceutical companies bridge the widening gap between supply and demand.
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![GettyImages-1312767504 data health]( "Using IRT Data To Automate And Optimize Clinical Supply")
Using IRT Data To Automate And Optimize Clinical SupplyLearn how clinical teams can save between $150,000 and $1 million in annual drug and shipping costs through automated supply optimization.
NEWS
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CTI Announces Additional College Of American Pathologists (CAP) Laboratory Accreditation2/21/2024
CTI Clinical Trials and Consulting, a full-service global research provider, is thrilled to announce that our North American laboratory facility has been granted the prestigious College of American Pathologists (CAP) Accreditation for Safety Testing.
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EPNextS Group And Frontage Laboratories, Inc. Announce Collaboration In Early Phase Clinical Trials In The United States To Improve ‘Drug Lag’ And ‘Drug Loss’ Issues In Japan3/26/2024
EPNextS Group, a Japanese based leading provider of clinical trial solutions, and Frontage Laboratories, Inc., a US based full-service contract research organization (CRO), have announced a collaboration aimed at addressing the challenges of "Drug Lag" and "Drug Loss" in Japan.
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Biosimilars Forum Scientific Publication Identifies Pathway To Streamlined Development For Biosimilars8/7/2023
A new peer-reviewed scientific publication from the Biosimilars Forum provides a comprehensive set of recommendations on how biosimilar development should evolve. The recommendations reflect current science and available evidence.
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Suvoda eCOA Earns High Marks In Patient Usability Study11/9/2023
RWS Life Sciences certification validates that Suvoda eCOA is intuitive and easy to use.
ABOUT
Clinical trials
Clinical trials refer to any research done in any medical field. The main objective of clinical research is to find solutions to better screening, preventing, diagnosis and treatment of diseases. Trends such as clinical trial globalization have been credited for the increased dominance of these trials in the medical field. Pharmaceutical companies have stepped a notch higher by not limiting their trials to their native countries. North American companies have moved to Asia and Eastern Europe since these areas offer lower costs and higher patient numbers.
Globalization comes with its own challenges since one has to conform to the regulatory standards set by the individual regulators in the new areas they venture into. The research infrastructure in some of these areas is not up to a similar scale to that in the areas a manufacturer operates in. Intellectual property ownership and biospecimen ownership might be issues that can lead to delay in commencement. These complications along with ethical issues might be limiting factors.
Clinical trials usually occur in three phases. The first phase involves human testing. This is important in establishing the amount required as dosage. The second phase involves accessing if the administration has an effect in relation to what is being tested. For instance, the second phase in cancer trials determines the anti-cancer effects of an administration. The last phase involves comparing the patients using a tested treatment with those in the standardized treatments.
Though some people are still skeptical about clinical trials due to the uncertainty, there are numerous others who are willing to participate in these trials. The principle investigators and their team are responsible for ascertaining the safety and the risks involved in a trial. One needs not to be worried since these professionals have credentials that will be applied in ensuring safety of all the participants.