AstraZeneca today announced that FDA has approved selumetinib for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA press release announcing the selumetinib approval is at https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-children-debilitating-and-disfiguring-rare-disease.
The SPRINT trial that was the basis for the selumetinib approval was an NCI/CTEP-sponsored clinical trial that led to selumetinib being available today for children with NF1-associated plexiform neurofibromas.
CTIS, Inc. is a contractor of NCI/CTEP that has developed and maintains CTEP-ESYS (CTEP Enterprise System), which was used to support the information and data needs during the conduct of this trial. CTEP-ESYS enables NCI/CTEP and the scientific community to focus on scientific opportunity, patient safety and finding better ways to treat, control and cure cancer.
CTIS is honoured to support NCI/CTEP in their distinctive role to bring this new medicine to children and adults in need of more effective therapies.
Consistent with her commitment to children’s health and education, Bharti Shah, CEO, CTIS, Inc. is joining hands with Children’s National Hospital to build the first of its kind pediatric COVID-19 test site in the country for the District of Columbia. Leading the effort against COVID-19, Rina Shah, CTIS’s Advisory Board Member for Strategic Development, is working on philanthropic efforts to raise funds, support Government and private sector industries and spearhead innovative technologies to help patients, providers and institutions.
The Shah family is honored to support Children’s National Hospital in their unwavering effort to provide the best possible care for our country’s children. “When I was approached by Children’s National with this unique opportunity it was a ‘no brainer,’ Mrs. Shah said. “In defining moments like these it is incumbent upon leaders in the community to get involved and see that needs are being met and the most vulnerable among us are taken care of. This facility is operational, and we need to make sure people in the area are aware and take advantage of this important service,” Mrs. Shah stated.
Mrs. Shah has a long history of supporting her local community as well as projects in her native country of India. Additionally, Mrs. Shah established a Montessori school which has been educating children for 20 years and continues to support non-profit organizations including NIH Children’s Inn and Children’s National Hospital.
Children’s National Hospital Launches Pediatric Drive-Up COVID-19 Specimen Collection Site
“The drive-up/walk-up site and other urgent needs are made possible by the generosity of philanthropists who raised more than 1 million dollars. It was jumpstarted by Scott Nathan and Laura DeBonis and matched by A. James & Alice B. Clark Foundation, The Bharti and Raj Shah Family and The UAE Embassy in Washington, DC.”
The Federal 100 Awards are the original and most prestigious awards in federal IT.
Please join us in congratulating CTIS CEO Bharti Shah on being named to the FCW 2020 Fed100 list. Read More
Congratulations to Sudhir Raju, CTIS, Inc. and NCI/CTEP team !!
CTIS team received the National Cancer Institute’s (NCI’s) Director’s Award “In recognition of outstanding leadership in the development and implementation of the Cancer Therapy Evaluation Program’s Clinical Oncology Research Enterprise” on December 5, 2019. The honor spotlights the CTEP CORE Development Group consisting of NCI staff and CTIS team members’ work with developing and implementing an enterprise-level information technology (IT) platform called the Cancer Therapy Evaluation Program’s (CTEP’s) Clinical Oncology Research Enterprise (CORE) and CTEP-ESYS (CTEP Enterprise System.
CTEP-ESYS is a suite of applications developed to support NCI/CTEP’s mission to improve the lives of cancer patients by finding better ways to treat, control, and cure cancer. The team includes NCI staff, and Sudhir Raju, Yogi Byreddy and Yvette Grainger from CTIS.
CTEP CORE represents a comprehensive, integrated IT solution that fully supports NCI/CTEP processes and its mission. It is an integrated collection of 40+ clinical trial research management applications that assist CTEP, other NCI staff, and the extramural community in many clinical trial domains, such as Information Security, study administration and logistics, clinical data capture and reporting, regulatory monitoring and reporting, data quality and control and correlative study data. CTIS team has developed and maintained CTEP-ESYS which includes 25+ applications and also worked with various NCI/CTEP contractors to integrate the systems to provide a seamless and efficient experience for the NCI/CTEP Branches and their stakeholders.
CTIS, Inc. is honored to be recognized by NCI Director for the collaborative group to establish the Clinical Oncology Research Enterprise!!
ROCKVILLE, MD – October 18, 2019 – CTIS announced that it has been awarded a $10 million contract with the Defense Contract Management Agency (DCMA) to provide sustainment services for DCMA enterprise suite. As a DoD Combat Support Agency, DCMA ensures the integrity of the contracting process and provides a broad range of contract-procurement management and administrative services to ensure valued product is being delivered promptly and ready for use by America’s Warfighters.
With this win, CTIS is excited to add another federal government partner and begin, what we hope to be, a long-term client relationship with DCMA. “We believe our software IT enterprise management capabilities and experience in modernization of IT systems will greatly enhance the DCMA enterprise systems.” said Sudhir Raju, President and COO of CTIS.
“We are very pleased DCMA selected CTIS Team for this work and look forward to growing our DoD footprint” said Bharti Shah, CEO of CTIS.
“We always strive to be true partners and focus on delivering outcomes for our clients.” stated Vivek Pillai, Senior Vice President of Integration and Business Development at CTIS. “CTIS will continue enhancing and sustaining DCMA’s 100+ legacy applications supporting the warfighters. CTIS’ delivery excellence, proven IT capabilities and innovative solutions are what we look forward to bringing to DCMA”.
About CTIS (www.ctisinc.com)
CTIS is a Women Owned Small Business, with proven expertise in providing informatics solutions for over 30 years. CTIS is amongst a few US Federal Government Contractors appraised at CMMI Level 3 using CMMI DEV 2.0 as well as a SAFe® Bronze Partner.
CTIS’ capabilities span the IT enterprise and associated operational lifecycles with extensive experience providing mission-critical oversight, strategy and planning for our government clients. We provide web strategy, IT program and strategic IT initiatives support, enterprise information management, big data, mobile applications, web development, optimization and production support, document management, web operations, software applications development and maintenance support, secure and robust infrastructure management, and training. CTIS supports its partner agencies by bringing unique and innovative approaches to offer leading technology solutions and empowering stakeholders.
CTIS is one of the first few organizations in the world to be successfully appraised using CMMI Version 2.0!
ROCKVILLE, MD – June 17, 2019 – CTIS Inc. announced today that it is one of the first 22 organizations in the world to successfully complete an appraisal under the new CMMI DEV Version 2.0. The CMMI Version 2.0 uses the Agile with Scrum context and improves overall business performance, leverages current best practices, builds agile resiliency and scale, increases value of benchmarking and accelerates adoption. CTIS has been appraised at Maturity Level 3 (ML3). CTIS’ first successful appraisal at ML3 was in 2007 and since then has consistently been appraised every 3 years.
In addition, CTIS has joined the Scaled Agile Partner Network as a Bronze Transformation Partner. Scaled Agile Framework ® (SAFe ®) transformation partners are equipped to provide training, coaching and consulting services to help customers achieve better alignment, cadence, synchronization, and collaboration across the organization.
CTIS is amongst a few US Federal Government Contractors appraised at CMMI Level 3 using CMMI DEV 2.0 as well as a SAFe® Bronze Partner.
CTIS’ early adoption of SAFe and the CMMI DEV V2.0 ML3 assessment confirms our commitment to our customers by delivering faster, more predictable and outcomes that are innovative, cost-effective, on-time and within budget. “We have employed SAFe with our customers to increase speed of delivery and higher quality results while enhancing our customers’ ability to balance changing priorities in addressing their mission critical needs” said Sudhir Raju, President and Chief Operating Officer at CTIS. “This reiterates CTIS’ Founder and CEO’s long-term commitment of integrating best practices in delivering solutions to the clients,” he added.
About CTIS (www.ctisinc.com)
CTIS is a Women Owned Small Business, with proven expertise in providing informatics solutions for over 30 years. CTIS empowers stakeholders, patients and providers with technology-based healthcare solutions. Using IT, CTIS helps organizations produce efficient and effective outcomes. CTIS’ business is the capture, storage, and use of information in health and biomedical science. CTIS offers a patient-driven approach to informatics — improving privacy, security, and safety. Within the healthcare industry, CTIS offers unique advantages including a boutique firm of IT experts; In-depth knowledge about medical and healthcare systems; Custom-tailored IT solutions; Collaboration with the government’s leading research institutions; Decades of experience managing data from clinical trials; and A visionary culture of innovation supporting clinical research, patient care and public health
About Scaled Agile, Inc.
Scaled Agile, Inc., is the provider of SAFe®, the world’s leading framework for enterprise agility. SAFe helps businesses address the significant challenges of developing and delivering high-quality software and systems in the shortest sustainable lead time. “Working with best-in-class partners like CTIS represents our commitment to helping software and systems-dependent enterprises improve time-to-market, quality, and employee engagement,” said Dean Leffingwell, creator of SAFe and cofounder of Scaled Agile, Inc. “By incorporating SAFe into their solution offering, CTIS is enabling the large organizations to become more Agile in seeing their ROI faster.”
About CMMI® Institute
A subsidiary of ISACA Enterprises, CMMI Institute is the global leader in the advancement of best practices in people, process, and technology. The Capability Maturity Model Integration (CMMI)® is a proven set of global best practices that drives business performance through building and benchmarking key capabilities. CMMI Institute elevates organizations to benchmark performance across a range of critical business capabilities, including software development, maintenance and operations, service excellence, workforce management, data management, and security. For over 25 years, thousands of high-performing organizations in a variety of industries, including healthcare and information technology, have achieved sustainable business success through CMMI adoption with demonstrated ability as capable IT contractors.
CTIS, Inc., Rockville, MD based Health Informatics company, today announced the promotion of Ms. Bharti Shah to Chief Executive Officer. She will have the primary responsibility of overseeing CTIS’ business operations and development for growth opportunities and initiatives. She will continue providing leadership, coordination and day-to-day management for business operations and direct the back-office overseeing the Accounting department, employee well-being along with the HR team.
Ms. Shah has been an integral part of CTIS history and its success. Ms. Shah has served CTIS in the capacity of Deputy CEO and Chief Empowerment Officer, she is an investor and co-owner at CTIS. Ms. Shah brings leadership and customer service experience and skills, she will lead to build CTIS’s future together with the team.
Ms. Shah has more than 20 years of professional experience in the field of education, having served as vice president, director, and teacher at Montessori Children’s House of Loudoun (MCHL). Although she has retired from teaching, she continues her philanthropic journey and believes it is important to give back to those in need globally and locally. Mrs. Shah has been committed to corporate citizenship through support of the healthcare needs of local and global communities, facilitating services in the areas of children’s health and education. She is actively involved in sponsoring more than 50 schools in India, providing management, strategy planning, and informatics support to the Ekal Vidyalaya Foundation. With the Arogya Foundation, she has worked to develop a pilot project that involves the use of handheld devices for the advancement of rural health. Mrs. Shah has been involved with many global health projects including the International Spirit of Healing, the Art of Living Foundation, Health Related Information Dissemination Amongst Youth (HRIDAY) & Student Health Action Network (SHAN), International Network for Cancer Treatment and Research (INCTR), International Spirit of Life Foundation, and Sri Sri University. Mrs. Shah has a bachelor’s degree in commerce and economics from Mumbai University and has a Montessori teacher training and certification from the Institute for Advanced Montessori Studies’ Barrie School.
Mr. Bill Yarnoff, joins CTIS, Inc. as the Executive Vice President of Growth. Mr. Yarnoff, is a veteran of the technology marketplace, having held executive positions with numerous solution providers to the federal government. He has held leadership roles in direct sales, sales support, strategic partnership and alliance development, go-to-market strategy formulation, project and portfolio management, corporate branding, training, and related initiatives. Most recently, Bill led the formation and launch of the ACEL360 accelerator for Federal Government contractors. Prior to that, he launched the Meridian International Institute, the revenue-generating arm of the Meridian Global Leadership Institute. At Meridian, Bill oversaw the development of a multi-module professional development program. He was also responsible for creating pipelines of high-value prospects, negotiating strategic agreements with partners, developing a professional faculty, and formulating an e-learning strategy. Bill holds an undergraduate degree from the College of William and Mary; he also attended the Professional Studies Program at the University of Virginia.
Dr. Teresa S. Sligh, MD, joins CTIS, Inc. as the Executive Vice President and Chief Medical Officer. She has served for 15 years as the founder and president of Translational Research Group, Inc., a special populations CRO and all-phase research center in Los Angeles conducting studies in internal medicine, endocrinology, infectious disease, chronic pain, gastrointestinal, respiratory, allergy and dermatology.
Dr. Sligh is returning to CTIS, Inc. where she previously served as the Chief Medical/Strategy Officer as an architect for CTRM, TrialBridge and other strategies.
Dr. Sligh is board eligible in Internal Medicine Research Path, having trained in Internal Medicine at Presbyterian Hospital of Dallas, Texas, and received her M.D. degree from Texas A&M College of Medicine. She completed graduate work in protease enzymology and received her Bachelor of Science degree in biochemistry from the University of New Mexico.
Initially as a biochemist, Dr. Sligh conducted basic research in metabolism, molecular and cellular biology. She subsequently worked as a medicinal biochemist in the analysis, characterization, manufacturing and quality of pharmaceuticals. Later she transitioned into clinical research serving as a drug development lead, CRA, IRB member, regulatory, quality and subject matter expert. In the past 20 years, Dr. Sligh has served as principal investigator on more than 450 clinical trials of biologics, pharmaceuticals, apheresis, cell therapies, devices, implantables, digital technologies (ingestible, wearable and handheld), real world, nutraceuticals and multidisciplinary therapies.
During her recent 10 year service as a board member for a publicly-held corporation, Dr. Sligh’s vision leadership resulted in the re-focusing and transformation of a blood bank company into a niche supplier in the bioresearch space providing cGMP compliant cell collections for emerging markets in cell therapy. This internal startup was grown from $0 revenue in 2011 to $20.2M revenue in 2017 with no debt or dilution yielding a 2017 gross profit of 53%.
Dr. Sligh dedicates her efforts to evangelizing and improving clinical research as well as to providing free medical care to underserved populations.
Mr. Raju brings over 20+ years of wealth of experience in the health IT industry ascending to several supervisory and management positions. He has led the development of innovative and effective solutions for the health industry. Under his leadership, the company has received numerous awards from the NIH and NCI Directors, and recognition from the Office of Management and Budget and project officers. He has led projects that involve process re-engineering, stakeholder management, architecture, analysis, design, development, and implementation of software solutions for the health informatics industry that have provided high outcome and return on investment to the clients.
Mr. Raju earned his bachelor’s degree in engineering from the Indian Institute of Technology, India. He holds a master’s degree in computer systems management from University of Maryland University College and an MBA from Cornell University. He is a certified Project Management Professional (PMP) and SAFe® Agilist.
“Sudhir has been a key part of CTIS history and our success, brings deep customer expertise and operational leadership to this position and we are excited to promote him to this important position” said Raj Shah, CEO and Chairman of CTIS, Inc.
February 21, 2017 – CTIS is pleased to announce that we have been awarded the Strategic Partners Acquisition Readiness Contract (SPARC) by the Centers for Medicare & Medicaid Services (CMS). This Indefinite Delivery/Indefinite Quantity (IDIQ) base ordering period will span over the next five years with the potential for optional years through 2026. The purpose of this contract is to provide strategic, technical, and program management guidance and support services, and to facilitate the modernization of CMS business processes and supporting systems.
About the Strategic Partners Acquisition Readiness Contract: SPARC is a multiple award, IDIQ, performance-based contract. A cost-effective, innovative solution, SPARC is available to all components within CMS and all Health and Human Services (HHS) operating divisions to procure information technology (IT) system development services from end to end.
July 25, 2016—CTIS in partnership with The Johns Hopkins Center for Clinical Global Health Education (CCGHE) in Baltimore, Maryland and the Byramjee Jeejeebhoy Government Medical College (BJGMC) in Pune, India launched a custom designed Mobile Health and Wellness Clinic in Pune, India. The mobile clinic will deliver healthcare services and wellness counseling as well as facilitate tuberculosis screening and research funded by Indian government and NIH in the state of Maharashtra in India. Innovative approaches that augment traditional service delivery are needed, such as mobile clinical care, to begin to address healthcare shortcomings. Read the article from Times of India and view the interior description of the van in this video.
Maharashtra is among India’s top regions for cases of both drug-sensitive and multidrug-resistant tuberculosis, and the service area for the clinic comprises a population of 7 million people that includes the city of Pune and surrounding villages. The mobile clinic is equipped with radiology technology, lab equipment, and a patient examination room. The vehicle will also offer tuberculosis screening, diagnostics, and treatment services for patients. “We are highly committed to affecting broad changes in India’s ability to address serious health issues,” said CTIS CEO Raj Shah, “CTIS is pleased to provide a tool that can be used to deliver care where it’s needed most.”
CCGHE Director Dr. Bob Bollinger noted “This effort is about improving the medical care that very sick people receive in an area that has limited healthcare resources. Raj and Bharti Shah are providing a tangible solution to address the problem of access to healthcare, and we hope their incredible generosity will encourage others to support our mission to save and improve the lives of Indian adults and children.”
About the Johns Hopkins Center for Clinical Global Health Education
The Johns Hopkins Center for Clinical Global Health Education (CCGHE): is dedicated to improving health outcomes in resource-limited communities by training, supporting, and empowering in-country healthcare providers and health researchers to develop and lead advancements in clinical research, practice, and policy.
June 28, 2016—CTIS is proud to announce that the Health Informatics Solutions (HIS) Group has been appraised at level 3 of the CMMI Institute’s Capability Maturity Model Integration (CMMI)®. The appraisal was performed by SPA Enterprise Services.
CMMI is a capability improvement framework that provides organizations with the essential elements of effective processes that ultimately improve their performance. An appraisal at maturity level 3 indicates the organization is performing at a “defined” level. At this level, processes are well characterized and understood, and are described in standards, procedures, tools, and methods. The organization’s set of standard processes, which is the basis for maturity level 3, is established and improved over time. Refer to the results on the Published Appraisal Results System (PARS).
About CMMI® Institute
CMMI Institute (CMMIInstitute.com) is the global leader in the advancement of best practices in
people, process, and technology. The Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. For over 25 years, thousands of high-performing organizations in a variety of industries, including aerospace, finance, health services, software, defense, transportation, and telecommunications, have earned a CMMI maturity level rating and proved they are capable business partners and suppliers.
CTIS is proud to support and participate at the 2015 Academy of Psychosomatic Medicine (APM) Annual Meeting held in New Orleans, LA from November 11 to November 14, 2015. This conference focuses on “The Art and Science of Communication in Psychosomatic Medicine”. The art of communication revolves around how we interact with our patients, our colleagues, as well as the world at large. The science focuses on our knowledge base, studies and research. The meeting provides a stimulating program which will touch on these varied aspects of communication. Please visit the APM site for more information.
CTIS is pleased to announce that we have been awarded a task order under the CIO-SP3 contract for the Cancer Therapy Evaluation Program (CTEP) Informatics and Computer Support beginning September 15, 2015 by National Cancer Institute (NCI). This task order will span over for the next 7 years. CTIS has been working on the CTEP informatics contract for the last 25 years. The purpose of this task order is to provide development, enhancement, maintenance, and integration support for the CTEP – Enterprise System (CTEP- ESYS) including work that involves other systems that are dependent on or integrated with the CTEP-ESYS.
About Cancer Therapy Evaluation Program (CTEP): The mission of the CTEP is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects.
CTIS exhibited and participated at the 2015 Government-wide Acquisition Contract (GWAC) The American Council for Technology (ACT) – Industry Advisory Council (IAC) Forum that was held in Washington, D.C. This conference discussed how the GWACs are structured to accomplish innovation and best practices around more Government engagement with Industry. The conference also focused on how GWACs brings uncompromising program delivery through quality IT Services during each stage of the acquisition process. Please visit ACT-IAC site for more information.
CTIS was invited by Dr. James Ecklund, Chairman of the Inova Neuroscience Institute to participate with Inova at The Society for Brain Mapping and Therapeutics (SBMT’s) 12th Annual Congress scheduled for March 6-8, 2015 in Los Angeles. Our session discussed “Metadata and Military Medicine” which was chaired by Dr. James Ecklund and Dr. Babak Kateb. During this session, CTIS presented on “The Integration of Social Media in Big Data Collection”. This conference brings together physicians, scientists, policy makers, funding agencies and industry to further the advances and applications in brain and spinal cord mapping and image guided therapies.
On March 3rd, CTIS’ CEO (Raj Shah) and CAO (Bharti Shah) received an award from the Inova Health Foundation, a community-based, not-for-profit healthcare provider. Inova Health Foundation works with individuals, corporations and foundations in the community to assure that everyone has access to healthcare. The award was provided for their generous support to Inova Heart and Vascular Institute (IHVI), Inova Translational Medicine Institute (ITMI) on genomics and Inova Neurosciences and Spine Institute which has made a significant difference in:
- Supporting critical research around complex neurological conditions involving brain, spine and nervous system
- Supporting patient education at the transplant center
- Supporting education for the nurses
- Conducting research that benefits transplant patients
- Securing new equipment, including iPads for the patients
On February 20th, CTIS’ CEO, Mr. Raj Shah, and CAO, Ms. Bharti Shah were invited to participate in a roundtable discussion with a small group of 18 people to meet with President Barack Obama. President Obama discussed healthcare, environmental and global economics. The White House has requested a follow-up meeting to discuss health disparities and other issues.
CTIS is proud to participate as a Platinum Sponsor at the International Conference on Radiation Biology (ICRB) 2014 that will be hosted by the Institute of Nuclear Medicine and Allied Sciences (INMAS), Delhi, India, from the 11th to the 13th of November. CTIS will support the special session “The Quantitative Imaging Network: Role of Quantitative Imaging in Radiation Therapy” coordinated by Dr. Pushpa Tandon from NIH, USA. The conference encompasses all the major disciplines of radiation sciences and highlights important research areas such as, induction of an effective anti-tumor response by boosting the immune system; prevention, assessment and treatment of radiation injuries; strategies for developing medical countermeasures against ionizing radiations. Please visit ICRB 2014 for more information.