A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Strategic Consulting

Our team has years of experience in planning and executing clinical trials as well as, analyzing and reporting clinical data to approval. Our experts provide hands on advice that range from study design to drug approval. InClin has a proven track record of providing a focus approach to solving unique challenges. Some examples of where InClin can assist with strategy and planning include:

CLINICAL TRIAL OPTIMIZATION

InClin has developed a unique service offering for sponsors that have a need to improve the performance of an on-going study without the need to replace an existing CRO. Our approach is based on core principles of project management and InClin’s proven success in optimizing several large phase 3 global clinical trials for sponsors working with both regional and global CROs.  InClin’s robust optimization process includes key steps conducted by seasoned staff to identify critical factors impeding project goals and providing mitigating solutions. These steps include, but are not limited to, the following:

    • Directed interviews with key personnel at the sponsor, CRO and site levels
    • Complete review of project plans and key documents
    • Identification of root cause issues and critical risks
    • Recommended strategy for immediate corrective actions to improve project performance
    • Seasoned resources to implement action plans as needed.

Our optimization team has proven success in benefiting our sponsors on large and small projects by:

    • Accelerating timelines
    • Realigning budgets within scope
    • Refocusing scope to better meet the project needs

Our process is based on an Interactive collaboration between InClin and sponsor’s internal project team and continuous evaluation of project performance and objective outcomes

CLINICAL TRIAL SUPPORT IN AUSTRALIA

Many sponsors conduct clinical trials in Australia due to its well-defined regulatory pathway, accelerated timelines to approval and its cost-effectiveness.  InClin’s local team, based in our office in North Sydney, can provide country specific guidance and strategic consulting to our clients which allows them to take full advantage of the benefits of conducting trials in Australia.  Our regional team know the sites, key third party vendors and processes that allow them to provide expert, hands-on expertise to support the logistics of setting-up, implementing and managing clinical trials in this region from start to finish.

Specifically, InClin can provide the following in-country strategic support services:

    • Set up the sponsor’s local subsidiary on behalf of sponsor to gain access to the Australia R&D tax incentive scheme
    • Serve as local director for the sponsor’s Australian subsidiary
    • Serve as the Local Sponsor for clients that do not have an established business entity in country
    • Act as the Local Sponsor, on behalf of our Clients, for all submissions to the local Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA) via the Clinical Trial Notification (CTN) process
    • For early stage clients, leverage InClin’s existing relationships with all the Phase 1 units to accelerate the HREC and regulatory approvals and study timelines
    • Assign local InClin resources in support of all study related functional services that qualify for inclusion in the Australian R&D benefits claims
    • Serve as a local advocate for the sponsor in-country

EXPERIMENTAL DESIGN AND PROTOCOL DEVELOPMENT

InClin has expertise in the design of simple to complex clinical trials. We utilize our cross departmental approach working with the client to ensure the design is robust and has the highest probability of success. Types of studies we have designed include:

    • Adaptive designs and simulation analysis to duplicate the ultimate study condition and assess the potential outcome
    • Parallel Designs (e.g., superiority, non-inferiority)
    • Crossover (Bioequivalence, Food Effect)
    • Dose escalation (e.g., 3×3 or 6×6 and MTD designs)
    • Repeated Measures
    • Sequential Designs
    • Study Design
      • Objectives
      • Endpoints
      • Alpha Spending Scheme (e.g., Hochberg, Westlake, Closed Testing)
    • Analyses (e.g., standard, non-standard, modeling, etc.)
    • Sample Size Estimation (EAST, PASS11, nQuery)