Cd3

About Us

A Clinical Biometric Service Provider

Cd3 provides Clinical Biometric services for Phase 1-4 clinical trials, EDC system development and implementation, eCRF development, data management, medical coding, SAS programming, statistical analysis, data warehousing and more.



Our Philosophy

    We're passionate about our work because we care about progress, each other, and the patients we work for. As a result, our culture is a blend of intensity and caring. We thrive in an environment that is not burdened with excessive layers of decision-making, allowing us to rally quickly to market place challenges and opportunities. And we think fun and work are not mutually exclusive concepts, and instead should go hand- in-hand. And in all our work, we keep our integrity at the center of our actions. Operating ethically is the only way we know how to work.

Our Culture

At Cd3 we don't just focus on business plans and strategies. We also focus on what it feels like to work here. We like an informal, non-bureaucratic environment where there is easy and significant interaction with senior leadership, and where creative ideas with merit are entertained rather than pushed aside in deference to the status quo. As a result, our culture is a blend of intensity and caring.

We especially celebrate diversity in people, but also in ideas, work style, and even our approach to the challenges for which we create solutions. Diversity is a significant and valued asset, and as such it is carefully cultivated and protected within our company.

We strive to maintain a culture of openness, in which everyone is a valued contributor and feels comfortable sharing ideas and opinions, and we encourage interactions within and across teams, so that working together is a pleasure instead of a burden.

Our People

The Cd3 team is characterized by competence, purpose and integrity driven by our passion for people and progress, we are intense about our work, but we're also caring and fun, and enjoy one another. We respect individual talent and contribution but always demonstrate interdependence and genuine team spirit. We want to make a difference, by ourselves and as a team, and we help each other achieve success.

We are entrepreneurs at heart who don't shy away from hard work. We want to enjoy day-to-day life at our company. That means we want to know that with skill and hard work, we can make a real difference here, and that we'll be supported in our efforts and recognized when we make that difference.

Our Commitment

Environmentally friendly

Cd3 and its employees are dedicated to a cleaner environment and the preservation of natural resources at home and at the office. We continuously strive to find ways to recycle and reduce energy consumption by actively recycling materials related to work and personal use, employing energy efficient lighting and company policies aimed at reducing waste, our reliance on paper and investing in alternative energy and clean air technology.

Inclusion

CD3 is an equal opportunity and affirmative action employer. We especially celebrate diversity in people, but also in ideas, and work style. Diversity is a significant and valued asset, and as such it is carefully cultivated and protected within our company. Cd3 offers a stimulating working environment, that values innovative ideas and encourage employees to strengthen skills and gain valuable experiences that help them grow professionally and enable them to excel in their everyday functions.

Employee Health and Wellness

At Cd3 we feel that our employees are our greatest assets. We support, inspire and care for each other, we encourage one another to adopt or maintain healthy lifestyles that promote physical and emotional health.

Good Corporate Citizenship

At Cd3 we are passionate about our commitment for innovation and science, the success of our clients, and ultimately the patients in need of new and effective treatments. Operating ethically is the only way we know how to work, assessing our activities to ensure that what we are doing is not only beneficial to our clients and employees but also our environment, and our community. Cd3 employees are involved in many charitable organizations by working as volunteers, advocates and supporters. Our efforts cover a wide spectrum of health, social, and environmental issues. Cd3 supports these activities by raising awareness and through corporate donations.

Cd3 Recent Contributions:

•Yale Cancer Center “Closer to Free Fund”
•The Cancer Foundation
•Multiple Sclerosis Foundation
•Sarah Foundation
•James Greenleaf, Jr. Memorial Scholarship Fund
•Guilford Volunteer Fire Department
•Operation Gratitude (Support our Troops)
•Killingworth Youth League

Collaboratively providing our services with a team based philosophy

Services

A Clinical Biometric Service Provider

The success of a clinical trial depends in large part on clear and reliable data, efficiently acquired and maintained through advanced technology and proven processes. Cd3 personnel have extensive experience with all phases of clinical trials. We are able to support your entire biometric service needs, from set up and conduct to review and close out independently of technology platforms, phases, therapeutic areas, and size of your projects. Cd3 provides Clinical Biometric services for Phase 1-4 clinical trials, EDC system development and implementation, eCRF and CRF development, data management, glossary coding, SAS programming, statistical analysis, data warehousing and more. Pharmaceutical clients often employ us to provide services that relate to one or two aspects of a drug development program. Biotechnology clients may use us to manage their entire programs. Other CROs, may call on us for the specialty services we provide. Whatever the client’s need, Cd3 strives to provide the best fit solution guaranteeing high quality, cost effective and timely services


Clinical Data Management

    Our targeted approach to Data Management provides quality controlled solutions to biometric project management challenges from data cleaning to glossary coding including but not limited to:

    • Data validation, review, and cleaning
    • Database design and implementation
    • Data Management Plan
    • Case Report Form (CRF)/eCRF design
    • Medical coding
    • Management of data from third-party providers
    • Data Transfers
    • Data conversion including CDISC SDTM
    • eCRF Archival
    • Study rescue services

EDC

Employing the best EDC solutions for your clinical Trials

In today’s competitive drug and device development environment critical decisions need to be supported by near real-time data collected through a validated and 21 CFR Part 11 compliant Electronic Data Capture (EDC) system. Our personnel have over 20 years of EDC experience and have designed, built and implemented high quality databases in multiple platforms for hundreds of studies. We are able to bring this experience to your project to tailor a system that suits the specific needs of your protocol, to ensure the data are accurately and rapidly collected and distributed to support findings and allow for informed decisions. We use leading technology platforms to provide our customers the efficiencies available through this technology, improving data access and productivity while reducing paper cluttering and cycle time. At Cd3 we have experience in the development and use of multiple EDC platforms and we are able to provide services as needed. We employ a modular approach to EDC and can support any of your clinical trial needs from full service to selected tasks.

EDC Selection

Cd3 has experience in the selection and validation of EDC systems. Our personnel have chair a global EDC selection initiative for a large pharma company, which included the review of over 70 tool, multiple pilots, selection and organizational restructuring to obtain the largest benefit possible. This selection process was discussed in a 2005 IBM article and it has proven successful ever since. When developing an EDC plan for your research project, we consider all aspects from system setup, data collection, system updates, and archival of study data. This will ensure that the data collected today will be of the highest quality and usable in a regulatory submission for the duration of the entire program and beyond.

Medical Coding

Glossary Coding

An important requirement of analyzing any data is the ability to meaningfully group the records. In the case of Adverse Events, Medical History, or Concomitant Medications, a sponsor must use an ICH authorized glossary. Per license agreements for these glossaries any company that needs to use the coded data, must have a current license. Cd3 maintains current licenses for both MedDRA and Who DD Enhanced glossaries. Cd3 works with your clinical team in assisting with establishing glossary coding conventions and performing study term coding. We are able to support all of your coding needs, from assigning the codes to utilizing them in the production of meaningful tables, listings and graphs. In addition to employing (CodexQ), a proprietary coding algorithm and synonym lists, Cd3 performs manual coding using a two coder process. This helps ensure that the codes selected are appropriate and accurate ultimately minimizing your medical review timelines.

MedDRA Glossary Coding

MedDRA (Medical Dictionary for Regulatory Activities) is a medically valid glossary for use in the regulatory environment developed by the International Conference on Harmonization (ICH). Cd3 maintains a license for the current version of MedDRA and is capable of coding on a bi-term or patient-term basis. We can support various scenarios for coding in-house, at the sponsor, or a third party coding group. We can transfer coding related data and queries in many different formats.

Who DD Glossary Coding

The WHO Drug Dictionary is used by pharmaceutical companies and drug regulatory authorities for identifying drug names, active ingredients and therapeutic use, in the course of drug safety surveillance. Cd3 is able to provide Who DD coding services based on a by-term or by term-indication basis, whichever the sponsor requests. We also support coding by sponsor standard, transferring the terms and queries as SAS or Excel files.

CTC Coding

NCI's Common Terminology Criteria for Adverse Events (CTCAE v4.0) published in May 2009 by CTEP is a list of adverse event terms associated with a severity grading scale. CTCAE v4.0 is used within the oncology research community as the standard for documentation and analysis of AEs occurring in cancer research; for defining protocol parameters such as maximum tolerated dose, dose modification, and for comparison of safety profiles between interventions. Since the adoption of MedDRA by the ICH, the NCI, industry and regulatory bodies identified a need for CTCAE revision and synchronization with MedDRA. In version 4.0, all adverse event terms will be single concept MedDRA terms. These changes have been made in order to increase the accuracy of adverse event reporting and the usability of the terminology set.

Biostatistics

Cd3 experience with the FDA and the EMEA standards provides advanced statistical methodology to help you meet regulatory and safety requirements. Our Biostatistics services include:

•Protocol development and power calculation
•Randomization and blinding schedules
•Statistical analysis plans
•Statistical programming in SAS
•Interim analysis support
•Database integration
•Adaptive design consulting and simulation support
•Data Monitoring Committee services
•NDA-ready data listings
•CDISC-compliant datasets
•Integrated safety and efficacy summaries

Clinical Study Programing with SAS

SAS is a “de facto” standard in the industry. When performing either an EDC or a paper based study with Cd3, SAS output is a standard deliverable. The data that is delivered back to your organization can be structured with SAS formats, labels, and other attributes to make the analysis, reporting, and pooling of the data as easy as possible. Cd3 has SAS programmers who are experienced in supporting clinical studies. They are familiar with working in a regulated environment and able to react to the emerging standards in the pharmaceutical industry.. Cd3 hosts its own SAS server which is properly scaled to handle even the largest studies.

Databases and Derived (calculated) variables

After the data is collected, entered, and cleaned, you need to create an analysis database. This database should be structured to support analysis of your clinical study data. This step requires the ability to program, validate, and document calculated variables, derived from complex algorithms discussed in the protocol, SAP, or from interactions from the study statistician. We can provide these to our clients as SAS transport files and many other formats.

Tables, Listings, and Graphs

When performing an EDC or a paper based study with Cd3, SAS output is a standard deliverable. The data that is delivered back to your organization can be structured with SAS formats, labels, and other attributes to make the analysis, reporting, and pooling of the data as easy as possible.

Incorporating External Data

No Study is complete until all of the data collected is brought together. The external data (non CRF data) needs to be incorporated with the main CRF data. Cd3 can combine the data into a single database, simplifying statistical analysis, and helping your organization to easily retrieve all of the data for regulatory submissions. Without proper planning the external data will be hard to combine with the CRF data due to disparate keys. Cd3 can coordinate this effort and ensure all data points can be related to each other.

Data Standards

Data Standards Development

Clinical Data Standards allow you to maximize the usability of your study data by enhancing collection, analysis, and reporting, improving safety monitoring, and ultimately streamlining the review and approval process for new investigational treatments. Under the ICH’s (International Conference on Harmonisation) guidance on electronic Common Technical Document (eCTD), CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data. A standardized clinical database supports efficient analysis and easy formatting to support your submissions in addition, standardizing your clinical study data reduce costs and Increase operational efficiency by automating repeatable tasks, minimizing writing and validation of code as well as re-programming of tables, listings and graphs for future studies.

CDISC Standard Support

The Clinical Data Interchange Standards Consortium (CDISC) is a neutral, platform independent organization that has been working since 1997 to develop global data standards that enable information system interoperability to improve medical research and healthcare. Cd3 understanding of current industry data standards ensures the appropriate standard is implemented from the beginning, and has the experience to transform metadata and produce compliant deliverables for your existing studies, reducing queries and delays, expediting reviews and ultimately improving you chance to successful submissions Our services include:

• CDASH Compliant Case Report Forms (Paper and Electronic)
• CDASH and SDTM Annotated Case Report Forms
• Data Compliance consulting
• SDTM Compliant Data
• ADaM Compliant Data
• Metadata and Data Repositories
• Comprehensive Quality Assurance
• Legacy Data Conversion and Harmonization

Cd3 has adopted the CDISC standards. All client database deliverables will be provided using this format unless otherwise requested. This will allow our clients to be ready for the next phases of clinical study development. Cd3 have created over 700+ SDTM and ADaM datasets, 570 have already been submitted and reviewed by the FDA. This experience allows us to format your data into CDISC layouts which will help with data reviews for due diligence all the way to regulatory approvals.

Beyond Individual Studies - Creating Safety and Efficacy pools

The development of your compound can be stopped at many points along the development timeline. When it gets a green light to proceed, the ability to make the next step easier will help in shortening the time it takes to prepare your submission. You can better evaluate your compound by integrating the individual study data together as well as save valuable time during the submission scramble by the standardization and pooling of your studies.

Cd3 can assist your efforts by:

• Creating a Data warehouse for you compound as each study is completed
• Migrating already completed studies into a Data warehouse
• Programming Integrated tables and graphs based on the data warehouse
• Converting a Data warehouse into a CDISC compliant structure

Central Randomization

Randomization ensures that each patient have an equal chance of receiving the treatments studied, minimizes variability of the evaluation by avoiding confounding factors and provides a basis for the statistical methods used in analyzing data. Several methods can be used to assign treatments at random, and the choice of the most appropriate method must be carefully considered before the trial is initiated.Cd3 extensive expertise can help you choose the most appropriate randomization method.

Biometric Resources

Cd3 provides highly qualified clinical research professionals to companies that are rapidly growing, expanding competencies or re-sizing their work force. We actively recruit, train and place personnel in functional roles vital to the clinical research process such as:

• Clinical Data Manager
• Clinical Data Programmer
• Clinical Database Designer
• Clinical Data Coder
• Statistical Programmer
• Biostatistician

Knowledge

Our experience originates from the knowledge gained through years of working on clinical studies and study integration efforts

Experience

A Clinical Biometric Service Provider

Biometric services revolve around standard data centric activities that are optimized with a variety of process and tool modifications based on the therapeutic area being studied. Employing a team experienced in your therapeutic area helps through the utilization of established processes and templates most appropriate for your therapeutic focus. Cd3 concentrates on key elements of your study and develops effective processes independent of the technology platforms utilized. Drawing from a store of standardized data collection tools, such as CRF pages, edits, tables, listings and graphs Cd3 helps increase your efficiencies by speeding the development of your critical study start up deliverables.

Cd3 personnel has worked on a broad range of therapeutic areas with extensive experience in:

• Oncology
• Infectious diseases
• Cardiovascular indications
• CNS

Oncology is a core therapeutic area of expertise for Cd3; we strive to meet the constantly evolving needs of oncology, from innovative study designs, AE and Tumor classifications and study reporting requirements. Oncology therapeutics’ developers are challenged with a unique set of issues and complex tasks when conducting meaningful clinical trials. We are familiar with the need to support the frequent data pulls that are achieved by cleaning the data as it is entered, so the medical experts can make their decisions with the best possible information.

In addition, Cd3 personnel have extensive experience with early phase clinical development. Led by a management team with decades of experience in the field, we are able to support your entire biometric service needs, from set up and conduct to review and close out independent of technology platforms employed, and to provide timely data to help the safety review of subjects for FIH (first in human), DE (dose escalation), and all early phase clinical studies

Our Team

Our management team started in big pharma and learned what it takes to support clinical studies. Just as important they learned what is needed to form a collaborative work environment.


Bill Baker

Co-Founder & Chief Executive Officer

Bill is co-founder and Chief Executive Officer of Cd3 Inc. He is responsible for all clinical operations, develops biometric and statistical plans and evaluates new technology and EDC platforms that best fit Cd3 client’s needs.

Holly Coulter

Co-Founder & Vice President

Holly is co-founder and Vice President of Cd3 Inc. She is responsible for establishing new business development.

Timothy Garrelts

Co-Founder & Chief Operating Officer

Tim Garrelts is co-founder and Chief Operating Officer of Cd3, Inc. He is responsible for establishing and managing business operations and planning for Cd3.

Contact


246 Goose Lane, Suite 202| Guilford, Connecticut|06437

(203) 404-7500
info@cd3inc.com