TConneX

TConneX has a history of successfully delivering innovative, effective, and efficient information technology and biosciences solutions to our customers.

Technology Solutions

Content Management

Full life cycle Content Management System development, integration, implementation, support, maintenance, and training.

CMS Overview

TConneX uses COTS, and custom developed solutions to implement the following systems:

  • Document and Records Management
  • Digital Asset Management
  • Web Content Management
  • Business Intelligence Dashboards
  • Collaborative web solutions

Business Process Outsourcing

TConneX can perform all of the processes associated with operating a Content Management System on behalf of its client, which allows the client increased flexibility in the deployment of its fixed resources. Outsourced solutions are provisioned on a private cloud computing infrastructure that conforms with FISMA requirements for Certification & Accreditation of Federal information systems.

Project Examples

COTS PRODUCTS

DocumentumEnterprise Content Management
Input AccelEnterprise Content Management
OracleUCM + WebCenter
SharepointCollaboration Software
kofaxDocument Capture Software
JoomlaOpen Source Solution
DrupalOpen Source Solution
Spring CMCloud Computing Based CMS

Software Development

Full Systems Development Life Cycle and integration services as well as maintenance and operations support.

Oracle Partner

TConneX is a proud Oracle partner specializing in Oracle technology product stack and implementation of Oracle solutions. We have developed significant expertise in Oracle products. Our development team consists of software engineers with Oracle Certified Professionals certification and tremendous knowledge of Oracle products. TConneX has a successful track record of delivery of innovative solutions.

Methodologies

TConneX utilizes Agile methods and Rational Unified Process (RUP), along with the associated Rational Tools and JAZZ platform, within its development methodology.

Project Examples

Biosciences

TConneX Overview

Combing strong IT expertise and bioscience domain knowledge, TConneX provides innovative, cutting edge and cost efficient solutions to life sciences. TConneX is an innovative science-related technology CRO. Since 2001, we have successfully delivered a wide range of NDA risk management and safety solutions as well as biostatistical, data management and regulatory support services to clients within the private sector (pharmaceutical companies) and to the Federal Government (especially the Food and Drug Administration).

With growing regulatory requirements, continued standardization of documents and data submissions, a continued focus is placed on safety, development of statistical methodologies in clinical trial study design and managing data from multiple sources. TConneX's expertise and experience help clients navigate through all the possible options, helping them with execution, thereby enhancing their ability to accelerate the clinical development process towards FDA approval, with minimum risk and lower cost.

Scientific Advisory Board

TConneX engages a Senior Advisory Board of leaders in Biomedical, Bioresearch and Biorisk Management. Their deep understanding and current knowledge provide experienced leadership, guidance in staff development, and approval, with oversight, of quality assurance programs.

Ross A. Pastel, Ph.D

Ross Pastel has over 26 years of service in the US Army in a variety of medical research and leadership roles. He is well-versed in military medical research, ranging from the lab bench all the way to programmatic review. He is a recognized subject matter expert in biological surety, the psychological effects of biological, chemical, radiological and nuclear weapons and more. Dr. Pastel served as Deputy Commander for Safety, Biosurety, Operations, Plans and Security at USAMRIID from 2003 to 2006. During this time he was the Responsible Official for the largest DoD Select Agent Program in the country. He implemented the new Department of the Army (DA) biosurety regulation in the DoD's largest laboratory, including implementation of a Personnel Reliability Program, and passed every CDC Select Agent Program Inspection and the initial DA Inspector General biosurety inspection. He led preparations for successful DA and CDC inspections of two biosafety level (BSL) 4 laboratory renovations and was intimately involved with drafting the DoD's Biosurety Directive and the US Army's regulations on biosurety and the select agent security program. Prior to this, Dr. Pastel also served the Chief of the Education and Training Department at USAMRIID from 2001 to 2003. He holds a Ph.D. from M.I.T. and a Bachelors from Harvard University.

Robert J Hawley, Ph.D, RBP, CBSP

Bob currently serves as a Consultant in Biological Safety and Security. During 2003 through 2011 he served as Principal Scientist and Senior Advisor, Science, at the Midwest Research Institute Global (MRI) in Frederick, Maryland. Some of his duties included providing biosafety threat and risk assessments and recommendations for existing biological containment laboratories, designs for new containment laboratories and veterinary facilities, and disease surveillance systems for human, animal, and plant diseases. He received the Council of Principal Scientists Science Award from MRI in 2006. During 1988 through 2003 he served as Safety and Occupational Health Specialist and Biosafety Officer, Safety and Occupational Health Manager and Chief, Safety and Radiation Protection Office at the United States Army Medical Research Institute of Infectious Diseases at Fort Detrick, MD. He also served as the Biological Safety Officer for the U.S. Army Medical Research and Materiel Command from 1992 to 2001. He holds a Ph.D. in Microbiology from the College of Medicine and Dentistry of New Jersey; an M.S. in Microbiology from the Catholic University of America, and a B.S. in Biology from Pennsylvania Military College. He has authored journal articles and textbook chapters on the subjects of Microbial Taxonomy, Chemistry, and Genetics; Plasmid-mediated Antibiotic Resistance, Rapid Diagnostic Technology, Medical Aspects of AIDS, Biological Safety; Biocontainment and Decontamination; Biosecurity; Protection Against Biological Warfare Agents;

John W.Huggins, Ph.D.

Dr. Huggins retired as Senior Scientist, Division of Medicine, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in 2013 after 33 years as a scientist working in BSL-3 and BSL-4 containment laboratories at USAMRIID, and Guest Researcher at CDC working with a large number of select agents including variola, monkeypox, Ebola and Marburg, including developing and utilizing small rodent and nonhuman primate (NHP) models to research pathogenesis and to evaluate drugs and vaccines. He discovered the causative agent of Korean Hemorrhagic fever later renamed HFRS and led human clinical trials that established efficacy in man in clinical trials in PRC resulted in Ribavirin being the standard of care. He led the smallpox antiviral discovery effort including cidofovir, CMX-001 (brincidofovir) and ST-246 (Tecovirimat). Dr. Huggins conducted many NHP studies of ST-246 including GLP trial. He served as Senior Scientist studying pathogenesis of monkeypox and variola in NHP, and established a human natural history clinical trial that evaluated disease in 240 subjects at a remote jungle hospital in the Democratic Republic of Congo (DRC).

Susan Zhou, Ph.D.

Dr. Susan Zhou currently serves as the Senior Director of Biostatistics and Chief Biostatistician at TConneX and heads up our CRO Data Management & Biostatistics Department. Dr. Zhou holds a Ph.D. in Biostatistics from the University of Pittsburgh. Dr. Zhou has approximately 15 years of career experience working in FDA CDER and CDRH centers. As a regulatory senior review expert at the CDER, Dr. Zhou performed, in timely fashion, a full range of scientific reviews of New Drug Applications (NDAs), Biologics License Applications (BLAs) and Investigational New Drug applications (INDs). Dr. Zhou won a number of individual or collaborative research statistical projects (RSRs). Dr. Zhou was, on a number of occasions, either a Principle Investigator (PI) or a sub-Principle Investigator, tasked with carrying out several regulatory-related CDER and CDRH research statistical projects.

NDA Risk Management & Safety Solutions

We specialize in providing pre-submission, risk management and safety solutions to clients for their NDAs using Oracle Web SDM/Empirica Study™ software. Our risk management and safety solutions enhance the client's ability to accelerate the clinical development process towards FDA approval with minimum risk and lower cost.

We provide the operation, daily maintenance and technical support of Oracle Web SDM/Empirica Study™ software to the FDA. This software is used by the FDA for regulatory submissions and to conduct thorough safety reviews and data compliance.

Biostatistical Services

Working as partner to our clients, TConneX is committed to delivering very high-quality and accurate biostatistical services, tailored to our clients' unique clinical study designs. Access to our clients' data is created in a format well suited to their project requirements.

  • General statistical consulting
  • Clinical trial protocol development ,review and verification
  • Statistical Analysis Plan (SAP)
  • Randomization of patients and schedule development
  • e-Submission preparation - SDTM annotated CRF, define.pdf or define.xml
  • Interim analysis and reporting to Data Safety Monitoring Board (DSMB)
  • NDA submission and review
  • Study report review
  • Annual report
  • Client face-to-face meetings with the FDA
  • Review and responding to FDA queries
  • Methodology research and reporting in regulatory area

Data Management

Data integrity is key in clinical trial success. The TConneX Data Management team is committed to providing the highest data quality ensuring accuracy, precision and security. We provide a seamless flow of data and constant communication to ensure that our clients' projects meet deadlines and milestones.

Our team is comprised of experts that aid in the management of clinical trial data and effectively prepare our clients for regulatory submission. We comply with Good Clinical Data Management Practice (GCDMP) and CDISC standards. TConneX has become highly recognized for developing innovative clinical data management tools that improve clinical trial efficiency and reduce project costs.

  • Data Management Plan (DMP) creation
  • Database development
  • CRF development/review
  • Data cleaning, revision and transfer
  • Data loading and reconciliation
  • Medical coding (MedDRA and WHODrug)
  • Responding to data queries
  • Laboratory data management
  • Serious Adverse Event (SAE) Reconciliation
  • Safety signal detection using Oracle WebSDM/Empirica Study™ software

Statistical Programming

SAS is the indisputable leading programming software in the Life Sciences industry. We leverage SAS technologies to monitor key study metrics and prepare your statistical submission to the FDA. We have worked with a number of pharmaceutical companies across multiple therapeutic areas using SAS software.

  • Leverage SAS technology to enhance efficiency
  • Conducting individual research and statistical modeling
  • Perform simulations for complex study design or individual research
  • Verification of published outcome and validation of existing computer programs

CDISC Data Compliance and Regulatory Submission Support

We understand the complexities of the regulatory submission process and have the in-house experience to be successful at the FDA. In order to effectively support an NDA submission, the client must engage a focused and dedicated team that is accessible, flexible and multi-faceted. TConneX's highly experienced and skilled cross-functional team works intimately with our clients throughout the regulatory submission process. We provide all the strategic regulatory support services to assist our clients prepare and defend their regulatory submissions. We work collaboratively with our clients and their other third parties to develop submission strategy and assist with developing the overall project plan and timelines.

  • Process improvement and CDISC SDTM/ADaM implementation and consulting services
  • Conversion of SDTM annotated CRF (blankcrf.pdf) and mapping specifications
  • Conversion of legacy raw datasets to SDTM datasets to ADaM datasets
  • "Define.pdf" or "Define.xml" verification
  • Pre-submission review
  • Interim and final reconciliation of FDA Form 1572 (Statement of Investigator)
  • NDA Submission preparation, review and verification
  • Preparation of FDA Reviewer's Guide

News and Events

USAMRIID IDIQ Contract

TConneX is proud to announce our selection to support the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) as a prime contractor on the recently awarded USAMRIID IDIQ. With a $249,000,000 ceiling, this cost-plus, multiple award vehicle, will serve to support USAMRIID as well as other federal research laboratories in the development of medical solutions, vaccines, drugs, diagnostics and information, to protect our military service members from biological threats. It also provides specialized capabilities including Biosafety Level 3 and Level 4 laboratories and a fully accredited animal research facilities.

Selected Projects

Project One

FDA renewed a five-year contract for TConneX to provide services to the FDA for the operation, daily maintenance and user support of Oracle WebSDM/Empirica Study™ software, used by the FDA for regulatory submissions and to conduct thorough safety reviews and data compliance.

Project Two

FDA CDER renewed a contract for TConneX to provide integrated data management and analysis services. TConneX assists the Principal Investigators (PIs) and supporting FDA scientific staff to analyze results from sponsored clinical trials to facilitate NDA review process. The tasks include statistical programming, CDISC data conversion and data analysis.

Project Three

Mitsubishi Tanabe Pharmaceutical America, Inc., Jersey City, NJ, selected TConneX, Inc. to provide technology services to manage all data aspects of their clinical studies and to support the design, implementation and maintenance of paper or electronic solutions for data acquisition in customer's clinical development.

Program Management

TConneX offers program management and program support services.

Overview

TConneX's PMO follows the PMI PMBOK as a guiding tenet within its management approach. Our Program Management support includes cost analysis, project support, technical analysis and integrated logistics support for government programs.

Standards

TConneX utilizes standardized, repeatable processes within its organization - a CMMI derived methodology - for Life Sciences and models its operational procedures based on ISO 9001:2008 and ITIL standards.

Project Examples

Systems Integration

TConneX develops middleware solutions to integrate different technologies.

Middleware Integration

SOA solutions and Java/J2EE technologies to facilitate:

  • Asset Management
  • Inventory Management
  • Industrial Automation

Enterprise Identity Management

Enterprise Identity Management integration to manage user identities and entitlements across multiple systems, utilizing the following identification mechanisms:

  • User ID and password
  • Security Tokens
  • Biometrics

Project Examples

Systems Integration

TConneX develops middleware solutions to integrate different technologies.

RFID

RFID solutions and real-time technologies (middleware and integrated hardware, as well as firmware development) to facilitate:

  • Asset Management
  • Facility Access
  • Industrial Automation

Enterprise Identity Management

Enterprise Identity Management integration to manage user identities and entitlements across multiple systems, utilizing the following identification mechanisms:

  • User ID and password
  • Security Tokens
  • Biometrics

Project Examples

There are a number of ways that our technologies can be applied in the real-world. Learn more in Products ›