OCT Southern California | Techsol Life Sciences

Thank You For Connecting With Us

We are delighted to meet you at the Outsourcing Clinical Trials Southern California Event. As a tech-enabled scientific process organization (TSPO), we specialize in providing modern eClinical technology combined with our value-focused CRO services for clinical development and post-marketing surveillance. We welcome you to meet Dr. Sanket at our booth to have a quick conversation about your prioirities and how we can align ourselves to help you.

Tell Us About Your Business Needs

    CDM, Biostat & SAS ProgrammingRegional FTE serviceseCTD Submissions & ReportingClinical & Non-Clinical Medical WritingClinical Trial Technology ServicesMedical Device Consulting Services
    Site Management SupportPharmacovigilance ServicesDesign and Maintenance of Large Disease RegistriesReal-World StudiesRegional Partnerships for Clinical TrialsMedical Affairs Professional Services

    Expected Therapeutic Area(s) Expertise:

    OncologyCNSInfectious Disease and VaccinesCardiovascularDermatologyGI & Hepatology
    EndocrinologyAllergy and RespiratoryRheumatologyOphthalmologyNephrologyReproductive Health

    What Best Describes You:

    Large Pharma / BiotechMid-Size Pharma / BiotechGenericEmerging BiopharmaMedical DeviceConsultant
    Educational InstitutionTechnology ProviderConsumer Health and GoodsPrivate EquityOthers

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    Our Latest Insights

    How to Proactively Prevent Clinical Trial Protocol Deviations and Protocol Violations

    Understanding the Importance of a Clinical Trial Protocol The fundamental objective of a clinical trial protocol is to provide common scientific guidance on how to conduct the clinical study in a regulatory-compliant manner and gather data that will ultimately provide answers on the safety and efficacy of the investigational medicinal product. The Guidelines for Good [...]

    Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials

    What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]

    Best Practices for Signal Management in Pharmacovigilance

    Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]

    Enabling eSource in Clinical Studies to Optimize Trial Quality

    Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The electronic data source or eSource is the data that is initially recorded in electronic format in this process. Biopharma and [...]

    Implementing Electronic Consent for Clinical Trial Participation

    Industry Background of eConsent In an attempt to address health authority concerns and improve patient confidence, companies and independent industry bodies have experimented with electronic consent (eConsent) using electronic media such as smartphones, laptops, and tablets. Despite positive outcomes, its implementation remained experimental until FDA officially released a guidance in December 2016. Following in FDA’s [...]

    Top 4 Trial Design Best Practices for Medical Device Clinical Studies

    What drives the growing complexity in medical device clinical trials? The medical devices industry has revolutionized medicine with significant advances in both detection and treatment of diseases. Clinical trials for medical device regulatory approval are designed to produce valid scientific evidence of safety and effectiveness for the intended uses. Moreover, sponsors must consider designing trials [...]

    Data Driven Site Selection for Clinical Trials in a Post-COVID-19 World

    Introduction to clinical trials site selection Site selection is a comprehensive process that involves analysing sites, patient community, investigator profiles and site infrastructure for conducting a successful clinical trial. Pharma companies often look for alternative site discovery strategies to deal with the constant demand in trial sites globally. A data-driven approach across the clinical trial […]

    4 Effective Strategies to Accelerate Site Selection to Activation

    Introduction to the site selection process Clinical research organizations (CRO) predominantly rely on the internal networks and investigator database to support a clinical study for a drug. As the clinical sphere continues to expand at a rapid pace, there is an upsurge in demand for clinical trial sites worldwide. CROs are striving for new sites [...]

    Aggregate Reporting – Significance, Classification and Challenges

    Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive [...]

    Literature Screening – Process overview, challenges en-route and the scope for automation

    Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug. The scientific [...]