Consulting Services
This form is for people applying for solicitation and will need to be submitted by June 2, 2024.
To learn more about our consultation services, please see below.
CITEC Clinical Core Functions
1. Clinical Trials support
a. Study Design Advisory
The CITEC clinical core is committed to collaborating with our valued partners to offer expert guidance on the intricate process of clinical trial design across a spectrum of diverse settings. Our dedicated team excels in supporting the formulation of robust hypotheses, articulating well-defined study objectives, and selecting relevant endpoints. Additionally, we will share our expertise in the creation of case report forms and the creation of IRBs and regulatory documents for clinical trial planning.
b. Data Management
In collaboration with the Dan L. Duncan Cancer Center Biostatistics and Data Management Shared Resource under the leadership of Dr. Susan Hilsenbeck, we will provide advice on Biostatistical Design (sample size calculation, and the creation of relevant statistical endpoints). The Data Management group within CITEC clinical core can make recommendations for Database Creation and data collection tools and methods.
c. Protocol and regulatory requirements guidance
Our team will help researchers navigate the regulatory requirements for clinical trials in different countries. CITEC clinical core can guide obtaining approvals from local regulatory bodies and ethical review boards. We can also facilitate the preparation of IRB applications and Informed consent forms. In addition to our proficiency in US regulatory processes, we take pride in our ability to support global registrations. This involves collaborating closely with local ethics committees and community leaders to address ethical concerns specific to each region. By actively engaging with stakeholders on a local level, we ensure that the informed consent process is not only ethically sound but also culturally sensitive.
2. Pathology advising
Our expert Pathologist Dr. Daniel Rosen will contribute by a) determining the correlation of new diagnostic technologies with existing gold-standard techniques, b) assisting in the standardization of the innovative technology applications, c) guiding study design and sample collection, and d) advice on the validity of the point-of-care diagnostic tools in different contexts.
3. Clinical Study Implementation
The CITEC clinical core will guide teams on site selection and patient recruitment strategies by aiding in the evaluation of the acceptability of the technologies, feasibility of the procedures and studies, and identifying and eliminating barriers to implementation taking into consideration regional characteristics. We are committed to ensuring that clinical trials adhere to ethical standards and respecting cultural sensitivities is crucial in this endeavor.
We will share our practical, real-world knowledge in providing advice on training programs for researchers, clinicians, and support staff involved in clinical trials. Capacity building ensures that the team is well-prepared to conduct trials and handle point-of-care diagnostic technologies effectively.
The clinical core also can aid in the selection and development of advisory boards and outreach of stakeholders with a global perspective. CITEC clinical core will promote collaborations with other academic institutions, research organizations, and industry partners.
4. Resource sharing
We are developing a portfolio of documents and resources that can be shared with our partners to aid them in the process of identifying the necessary documentation to launch their projects.
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Examples of existing documents that meet regulatory standards and requirements (i.e. informed consent forms)
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Templates (i.e. Site Feasibility Questionnaires, Advisory Board brochures)
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Formats
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Guidelines: We will create a list of resources of Federal and International guidelines.
CITEC Technical Core Functions
1. Technology development support
The CITEC Technology core is committed to collaborating with our valued partners to offer expert guidance on the intricate process of sensing systems development including advice in are of design, fabrication / manufacturing (to select appropriate technology) and finally to help in prototyping and testing initial devices.
2. Design
Our dedicated team excels in supporting the optical detection / sensing and imaging. Specifically we will provide optical design expertise with access to ZEMAX design software at Rice facility. The design support can be at both complete design and consultation level. As mentioned above, one of crucial aspects of optical design is to properly include fabrication tolerances into the process so the system is manufacturable and cost effective. Understanding of manufacturing conditions is critical for the success of designs. The tolerance will include both optical and opto-mechanical considerations. In addition, we will advise on utilizing off-the-shelf components through ZEMAX macro analysis (of possible design combinations) and automatic search/mining of optical component catalogues.
Note that we are also experienced in assay/contrast design and implementation.
3. Prototyping
The manufacturing facility at Rice includes range of tools allowing optical, opto-mechanical prototyping and limited volume production of selected components. Example of these tools include diamond and general machining (turning and milling etc.), injection molding, additive 2-photon-polymerization, grayscale lithography etc.. Specifically, major instruments are 4-axis UPL250 Nanotech diamond machining lathe (allowing diamond turning and milling, ruling and raster fly-cutting with nm surface level quality), Milacron Roboshot 17-ton injection molding allowing up-to 50 grams part production, HAAS 4axis CNC for mechanical processing, and state of the art photonic fabrication unit Quantum X from Nanoscribe. In addition range of FDM 3D-printers and laser cutters is available for prototyping purposes. Within the program efforts we will discuss appropriate manufacturing options and will work with toward fabrication of critical components for CITEC collaborators and partners.
4. Component testing and evaluation
The evaluation of imaging/detection systems can be performed at individual components as well as the entire imaging system level. This includes measurement of optical characteristics of materials, stress testing, roughness, and form measurements. Deficiencies in components can significantly reduce imaging/sensing performance. CITEC’s facility includes instruments like the Atago refractometer (refractive index, Abbe number testing), custom circular polarimeter system, NewView 5000 from ZYGO optical profiler for roughness measurements, and ZYGO Opt250 Fizeau interferometer for form evaluation. In addition, CITEC has access at RICE to testing of optical materials for fluorescence background using FluoroLog®-3 spectrofluorometer (HORIBA Scientific). Complete imaging systems can be evaluated for imaging performance through assessment of modulation transfer function and Strehl Ratio using a slanted edge test bed and imaging with a range of ultra-high resolution targets. The testing will be primarily focused on devices and components developed/prototyped within the program.
5. Design/results management
Our team will help researchers through a depository of prior designs and developments. This will include prior publications and their designs and protocols and (by permission of collaborator / CITEC partners) designs performed during the CITEC’s sub-projects. The depository will be continuously updated throughout the program’s progress.
6. Resource sharing model
Beyond developing a portfolio of documents and resources (see section d) that can be shared with our partners to aid them in the process of design and system development and to help their projects, we will enable access to manufacturing/testing facilities on a service model base. In practice, it will mean that CITEC’s staff will perform fabrication and evaluation tasks at cost value. This cost will be limited to supplies/material costs used within the fabrication and some facilities/access fees and incidental staff time costs (for example, to shared equipment authority SEA at Rice).