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CRO Preferred Program Partners
Advancing Oncology Research. Engaging the Power of Community.
ADB Consulting provides services that identifies, develops, implement, and qualifies solutions required to initiate and conduct clinical studies from the Data Management and Bio-Statistical perspective. They provide solutions to these challenges by:
Amarex - A full service CRO headquartered in Germantown MD. Providing clinical development and regulatory strategy consultation, and PI through PIV trial conduct in an unlimited range of therapeutic indications and product types. Providing U.S. and International trial conduct and regulatory submissions.
Beardsworth is a full-service CRO. We specialize in complicated trials in difficult therapeutic areas. We are an oncology niche provider. Beardsworth has recently conducted 50 oncology and oncology-related clinical trials. While we specialize in oncology, we have broad-based experience in other therapeutic areas, including endocrinology, cardiovascular, immune response systems, dermatology and infectious disease.
Clinilabs is a global, niche CRO that provides clinical development services to life science companies involved in the development of central nervous system (CNS), cardiovascular and other therapeutics. The Company offers a robust portfolio of services to fit the needs of large and small clients alike, including scientific consulting, protocol writing, project management, study monitoring, data management, statistics and reporting. Many clients benefit from use of the Company’s dedicated, 60-bed Phase 1 unit for early-phase development, proof-of-concept, or cardiac safety studies; from the use of its international panel of certified investigators for multi-center studies; or from the use of its multi-million dollar electronic data center, which provides a comprehensive range of Part 11-compliant electronic data capture and management services, including the processing of eCRF, clinical laboratory, IVRS, ePRO, EEG, quantitative EEG, EMG, ECG, ABP and actigraphy data.
Criterium Inc. (www.criteriuminc.com) is a full service, global and technology driven contract research organization that offers a unique mix of high-quality, innovative clinical research solutions for the biopharmaceutical, and pharmaceutical, medical device and CRO industries. From thought to finish, Criterium provides timely and accurate clinical trial data and support services at every phase of development allowing customers to make sound and cost effective decisions about their clinical trials. Drug development companies can benefit from Criterium’s expertise, high-value services and products and high-end results. Founded in 1991, Criterium’s services are customized to fit each client’s specific needs, providing a seamless flow of data and information from the investigative site through Criterium back to the sponsor. To learn more about the Criterium Edge, visit the website. Criterium has corporate headquarters in Saratoga Springs, New York with offices in Florida, California, South Africa, India, Netherlands, Israel, Russia and Canada.
Cross Trained Data Professionals
Cross-Trained Data Professionals LLC is a Clinical Research Organization which focuses on providing quality consulting services to other CROs, large pharmaceutical companies, hospitals and other research facilities. We specialize in data management services, as well as statistical analysis and reporting. We also provide project specific tasks depending on the needs of the client.
Cu-Tech is a full service contract research organization offering a complete array of services to the client from the inception of a potential product on. Cu-Tech professionals specialize in Dermatology clinical trial management and monitoring.
Life Sciences organizations face significant challenges with meeting needs that arise during the drug and device development lifecycle. With resource specialization in all aspects of drug and device development, Delta can assist in the success of your clinical trials by handling your contract and permanent staffing needs. Delta’s staffing practice concentrates on ensuring the integrity of clinical trials through placement of highly skilled clinical research, scientific, and technology resources.
In addition, the Delta Outsourcing team provides a full array of offsite, project-based services including but not limited to Medical Writing, Medical Monitoring, Safety Operations, Clinical Study Management and Monitoring, Data Management, Statistics, Regulatory, and Quality Assurance. The team’s vast experience allows Delta to provide outsourcing solutions for complex projects within a variety of therapeutic areas. Furthermore, our international presence allows for a diversified knowledge base of global regulations as well as the ability to provide temporary onsite needs in many regions and countries. Delta takes pride in providing clear, concise, and high quality deliverables. We understand the true importance of having the most experienced and technically skilled staff members devoted to your pharmaceutical and biotechnology industry projects.
Diverse Lynx, LLC.
Diverse Lynx, a leading IT consulting and solutions company actively engaged in clinical trials and data management services, emphasizes long-term, value added relationships with customer business needs by leveraging proven industry experience and expertise. Diverse Lynx’s customized IT Solutions are product, platform and technology independent. The company also provides comprehensive Clinical Trials & Data Management Services to the pharmaceutical, biotechnology, generic drug, and medical device companies in the areas of General Medicine/Cardiology, Infectious Diseases, Neuroscience, and Oncology therapeutic areas. Headquartered out of New Jersey, USA, Diverse Lynx works closely with partners in Europe, India and Japan.
DSP Clinical is an award-winning, full service Contract Research Organization (CRO) dedicated to the management and execution of Phase I through IV clinical studies. DSP drives top-tier success for domestic and international studies for small to mid-size pharmaceutical, device, and biotechnology companies through unmatched experience, passionate leadership, aggressive strategies, and operational excellence.
Their services include overall project management, study site management, study and site monitoring, data management (including Electronic Data Capture), statistics, medical writing, and FDA submissions.
eClinical Consulting Group
eClinical Consulting Group is a full service contract research organization offering a wide range of comprehensive clinical research services to the pharmaceutical, biotechnology and medical device industries. Through the utilization of new generation internet platform research capabilities, eClinical Consulting Group integrates information capabilities into a user-friendly workflow-oriented process that effectively brings investigators, sponsors, and regulatory compliance officers together. The firm specializes in delivering data management services using state of the art electronic data capture (EDC) platforms. The company offers services in data safety monitoring, adverse event reporting, statistical analysis, system integration, and study execution. Moreover, eClinical Consulting supports patient recruitment, IRB and study monitoring, project planning, study design, protocol compliance, and milestone management. The organization strives to deliver the highest quality data and targeted enrollment while efficiently meeting projected time lines with successful clinical project completion. eClinical Consulting group is a women’s minority business enterprise.
Our Mission is to offer an alternative to post-marketing clinical practices through innovative programs that focus on the relationships between practitioners and their patients. Phase IV Clinical Experience Trials Registries REMS IITs
Global Pharmatek is a full service CRO located in Piscataway, New Jersey, USA, branch offices in Munich, Germany and New Delhi & Hyderabad, India. Global PharmaTek (GPT) is a premier enterprise-class clinical software and FSP, offers unique blend of both clinical trial domain and core IT life sciences expertise with thorough understanding of industry and regulatory standards. GPT provides services- Phase I QTc cardiac safety studies in cancer patients and healthy subjects, and Phase I - IV clinical trials, global clinical sites, medical and drug safety & pharmacovigilance monitoring, signal detection, risk management, medical monitoring and advisory board consulting, data management services, and regulatory compliance. We are specialized in Oncology, Neuro-psychiatry, and Cardiology therapeutics and clinical trial patient’s care.
Innovative Analytics supports clinical drug/device development programs with standard and innovative data management, statistical, and medical writing services. Our database and analysis processes are ICH and GCP compliant. We have extensive experience with the content of and eCTD formats for US, EU, and Japanese regulatory submissions for various therapeutic areas and orphan drugs. These include INDs and NDAs for drug applications, as well as PMAs and 510(k)s for device applications.
We provide large and small clients with flexible “turn-key” support, resource augmentation, and consulting arrangements.
LMC Endocrinology: Making Healthy Easier
LMC Endocrinology Centres are multi-disciplinary regional Centres of Excellence, committed to providing state-of-the-art Complete Care in Diabetes, Endocrinology & Metabolism. Each centre is designed to provide community-based access to service excellence through our focus on the key needs of our patients. Our commitment to enabling wellness, embracing learning and expanding the therapeutic horizon is integrated into all aspects of our centres.
Each of our centres of excellence provides direct care by experienced specialists in Endocrinology & Metabolism. Our centres cater to our communities through unique workshop design for the specific community, culturally sensitive educational materials and other tools to enable wellness in our patients.
Our Endocrinology specialists have participated in over 200 Clinical Research Studies, at the forefront of medical research. Embracing our credo of expanding the therapeutic horizon, we continue to help develop future therapies and provide early access to these promising tools to our patients.
Our innovative approach to providing centres of excellence in our communities has been acknowledged by both our patients and the surrounding communities. We were the first community-based Diabetes Education Centre provided with Ministry of Health support (2005) and were subsequently named the 2006 winner of the Oakville Business Awards of Excellence for Entrepreneurship. Still, the greatest testament to our centres of excellence is the increase in our patient base with over 20,000 new patients entering our clinics each year.
Our commitment to providing optimal Endocrine health care to each patient extends through all members of our multi-disciplinary team. Working together, with the latest in education, tools and therapies, we provide the most complete care in disorders of Diabetes, Endocrinology & Metabolism.
MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries. The company offers site selection, patient recruitment, PMO, clinical data management, edc, clinformatics, clinical monitoring, medical writing, PMS/PharmacoVigilance, biometrics, call centre, regulatory assistance, and quality assurance. MakroCare has offices in USA (New Jersey, Illinois, Pennsylvania, California), India (Hyderabad, Mumbai, New Delhi), Japan (Tokyo), and Europe (Frankfurt).
MaxisIT Clinical Functional Services acts as a true extension of customers' functional department resulting in an amenable cultural & technological integration with a long term commitment. Our capabilities are derived from a unique combination of best people, processes, state-of-the-art infrastructure and advanced technologies. As a value proposition, we offer dedicated multi-disciplined teams that are completely customizable, portable, and specifically designed to enable re-use of existing infrastructure while reducing the total cost of ownership.
MaxisIT's CTRenaissance® and clinical FSP enable its pharmaceutical and life sciences industry customers realize their vision of a safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market. Some of the key software-enabled offerings are: CDISC Conversion | Data Integration | Data Standardization to Electronic Submission | Statistical Computing| Protocol Design | Electronic Content Management
Since 1984 researchers have trusted the data from McDougall Scientific Ltd. Your data is a gift from the patients - we help unwrap it, and tell its story. The company has a well-deserved reputation for innovation, quality and cost competitive services. The computing infrastructure is compliant and support by a full business continuity plan.
Statistical analysis and design is a core service; statisticians are accredited, with years of training and experience in clinical trials and healthcare research. The designs are innovative (e.g. adaptive designs) and adhere to best practices. The analysis is rigorous and the programming validated.
Data Management in both paper and EDC is performed by SCDM certified data managers; full data logic checks, certified coding, Data Management Plans.
IVRS (Interactive Voice Response System) - Secure accurate randomization – even complex designs; Automatic trial supplies management; subject responses (ePRO); Reasons for screen failure.
Document Management – includes Trial Master File (eTMF)
Novella Clinical is a full service clinical research organization dedicated to clients in the oncology, medical device and biopharmaceutical industries. For over a decade Novella has served as a trusted outsourcing partner for Sponsors. Novella’s transparent, collaborative and proactive approach to clinical trial management allows our clients to move products to market faster and into the hands of people who need them.
Paragon Biomedical specializes in customized, international Phase I-IV clinical trials management. With offices in the US, UK, Poland and India, we deliver expertise, services and resources through clinical and data operation management teams experienced in local customs, culture, language and regulations. We are large enough to manage any clinical trial, yet agile enough to deliver leading edge, customized clinical solutions. We tailor our deliverables to meet your most specific demands. Your freedom of choice, combined with our personal commitment, ensures efficient execution and exceptional results. Paragon is certified as a Woman-Owned Business.
PCR Device Trials
PCR Device Trials is a multi-disciplined, full-service CRO specializing in device clinical trials, with particular expertise in the endovascular and cardiovascular areas. PCR’s clinical trial experience, particularly in drug-eluting stents and endovascular stent grafts, spans the range from First in Man to Post Marketing Surveillance Trials.
Pharma Medica Research Inc.
Pharma Medica Research Inc. is a full service contract research organization based in the greater Toronto area whose focus is primarily on early phase clinical trials in healthy volunteers, special populations, and patients. By remaining specialized in this area, Pharma Medica Research Inc. has developed true expertise in the field. Their track record speaks for itself – having completed over 2000 clinical trials, been successfully audited by the FDA, EMA, and ANVISA, been certified for GLP compliance, and helped to bring over 250 drugs to market. Through an uncompromising commitment to quality and service, a reputation for on-time performance, innovation at all levels, and delivery of services at reasonable costs, Pharma Medica has become trusted partners of many of the world’s leading pharmaceutical companies.
harmaPros’ team of industry veterans engages with Health and Life Science organizations to create, integrate, and manage their clinical information through its unique Data Lifecycle Management approach. Working with companies both large and small, PharmaPros provides advanced solutions for organizations focused on gaining visibility and access to data, working within aggressive timelines, internalizing clinical trial operations using external resources, and companies trying to integrate and consolidate data from multiple service providers and sources.
Pharmatech, Inc., headquartered in Denver, Colorado, is a Research Management Organization (RMO) dedicated to the highest quality of clinical research, while protecting patient safety. Pharmatech provides services of a Site Management Organization (SMO) and a Contract Research Organization (CRO) with a focus in oncology clinical trials. Pharmatech focuses on access to patients and clinical investigators through organized research networks. The Pharmatech Oncology Network consists of over 1200 community-based cancer researchers that provide innovative treatment options to cancer patients through clinical trial opportunities. The Network model provides a foundation for the development and utilization of therapeutic products among sponsors, investigators and patients.
The team of clinical professionals at Pleiad Devices specializes in clinical research support specifically for medical device companies. The company understands the regulatory issues in North America and Europe and provides quality clinical research services that serve regulatory, marketing and reimbursement clinical research needs internationally. Pleiad ensures compliance with all FDA and EU clinical research regulations so that all clinical data meet the regulatory standards of the major medical device markets. The clinical team offers expertise in a wide variety of areas including endovascular surgery, orthopedics, gynecology, tissue ablation, ophthalmology, combination products, drug delivery technologies and nanotechnology.
Prism Research is a phase I-IV clinical trials, 52 inpatient bed trial site located in the heart of the Minneapolis/St. Paul metropolitan area. Strategically located in a community of over 3 million residents with a rich tradition of medical care advancements, we offer a highly trained, dedicated staff, facility, expertise and volunteers to ensure your trial expectations are met or exceeded. Please learn more at http://www.prismresearchinc.com.
QST Consultations, Ltd. is an independent consulting firm that specializes in clinical study design, protocol development, CRF design, data management, biostatistical analysis, report writing services and statistical consultation services for the medical device and pharmaceutical industries. QST Consultations has been involved in many successful Phase 1 through Phase 4 clinical trials in support of 510 (k), PMA, ANDA, and NDA submissions. Our client base ranges from start-up companies to large major pharmaceutical companies across the US. QST's primary focus is to meet the goals of each client through personalized service and technical expertise. QST Consultations, Ltd. was founded in 1974 and incorporated in 1985.
Based in Chicago, IL, Radiant Development (www.radiantdevelopment.com) is a full-service CRO founded in 1995. The range of services includes medical affairs, site selection, project management, clinical monitoring and site management, data management, biostatistics, medical writing, pharmacovigilance, and quality assurance. In addition, specialized services such as protocol design, expert patient recruitment planning and execution, as well as scientific and regulatory consulting are available. Historically, Radiant Development's past clinical trials supported NDAs, supplemental indications, advertising statements, and health claim petitions. Radiant Research, Inc. (www.radiantresearch.com), based in Cincinnati, Ohio, is a comprehensive clinical research company offering study conduct, development and centralized patient recruitment services to the biopharmaceutical and medical device industry. Radiant is comprised of a full service CRO, 24 wholly-owned premier clinical research centers, and a centralized patient recruitment company, employing over 400 clinical research professionals. Radiant has conducted more than 8,000 clinical trials across 18 therapeutic specialties.
Research Dynamics, founded in 1993, is a privately held woman owned Contract Research Organization that provides services and management for Phase I-IV clinical trials for the pharmaceutical, biotechnology, and medical device industries. The company is a leader in SOP development, and, as one of the top providers in the industry, provides training and research products to a wide range of clinical research professionals. Research Dynamics specializes in providing high quality clinical research services cost-effectively through the use of leading edge technology and experienced people. The company, headquartered in Rochester, NY, has been named a "Rochester Top 100 Company" for the past three years. CEO/President Lorraine D. Ellis was named Entrepreneur of the Year 2004 for the use of technology in her company.
Research Assist is a contract research organization (CRO) providing clinical trial management services in the area of project development (e.g., protocol writing, IDB development, IND application, selection of vendors, identification of sites, etc.), project implementation (e.g., site qualifications, contract negotiations, conduct investigator meetings, regulatory document review, site initiations, etc.), clinical trial management (e.g., management of site activities, monitoring and tracking of study specific safety and efficacy data, processing of SAE reports, etc.), monitoring, data management, medical writing, clinical pharmacology and regulatory support.
Why RAI? We have a solid infrastructure and a core team of experienced and well qualified professionals to support our efforts in conducting phase 1-4 clinical trials. Each of our core member has greater than 15 years of industry experience, most greater than 20 years managing global clinical trials. With this level of experience, our clinical trials are individually managed with oversight of every detail. The end result is an efficiently run clinical trial, decreased queries and a rapid database lock. Our customers return to us, because they have gotten used to a level of quality they know we will always deliver.
Symbiance is a dynamic and growing contract research organization. Symbiance’s operations are built on a history of providing clients with exceptional services in clinical data management and biostatistics, as well as medical writing and regulatory affairs. Symbiance has been very successful in the statistical analysis of data and the writing of eCTDs, including ISEs and ISSs. Symbiance is also experienced in converting raw data into CDISC-compliant datasets (SDTM and ADaM). Additionally, we excel in integrating and hosting global clinical data for use in data mining and regulatory submissions. Our forte is cost-effective, efficient, and reliable services. Symbiance is dedicated to meeting the challenges of the future. We continue to strengthen our analytical capabilities through the acquisition of advanced database and data transmission technology, while utilizing the latest statistical methodologies. To assure quality and continuity for our clients, we are committed to hiring and retaining personnel with extensive experience.
TAB Clinical Trials is a full service CRO providing clinical trial support from a pre-IND stage of development to post-market approval. Based in the RTP area of North Carolina, TAB Clinical concentrates on helping small, mid-size and specialty biopharmaceutical and pharmaceutical companies expedite the pace of drug development through efficient and cost-effective processes combined with attentive and responsive project management.