Our team of Advarra Consulting experts prioritizes your unique goals, challenges, and timelines. We work collaboratively with your research and development team to accelerate product development and performance, making clinical research safer, smarter, and faster.
Clinical research involving human participants typically involves some type of risk. Incorporating the appropriate ethics reviews and safety oversight helps ensure stakeholder safety, data integrity, and regulatory compliance. Includes IRB, IBC, DMC, and EAC.
Centralize research operations within Longboat globally for all sites, sponsors, and contract research organizations (CROs) to accelerate study startup, guide efficient and compliant study conduct, enhance patient outcomes, and streamline critical coordination.
Think beyond the binder. Save money, improve efficiency, and enhance regulatory compliance across your organization with a 21 CFR Part 11-compliant system designed to adapt to regulatory workflows for any size research site.
Clinical Conductor is a comprehensive Clinical Trial Management System (CTMS), scalable to optimize finances, regulatory compliance, and overall clinical research operations for all types of research sites, site networks, hospitals, and health systems.
Gain visibility into all aspects of your research operations with a comprehensive, proven, and standardized clinical trial management system built through collaboration with leading academic medical centers and cancer centers.
Paladin Labs Inc. is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing and sales organization that has helped it evolve into a well-known Canadian specialty pharmaceutical company with a breadth of products.
Par Pharmaceutical: High-Quality Generic Products
Par Pharmaceutical develops, manufactures and markets innovative generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and other differentiated products.
(collagenase clostridium histolyticum) for injection, for intralesional use
OmnisiteTM is a flexible site model that reaches patients at home and in their communities for faster recruitment, greater patient diversity, and expanded access by reaching geographies untapped by traditional sites.
Achieve faster, more efficient studies with our fully customizable eClinical suite, featuring ePRO/eCOA, eConsent, Telemedicine, eSource, Site Portal, Payments, Scheduling, EDC, Home Visits and much more.
4C SupplyⓇ addresses the increased pressures on clinical supply professionals to minimize waste and avoid stock-outs as clinical trial complexity continues to rise.
Prancer RTSMⓇ Rand-Only offers simplified patient tracking for studies that require randomization where inventory management is not a priority.
Prancer RTSMⓇ Inventory Platform provides transparency into how much drug will be needed to support ISTs so you can balance a high volume of requests in relation to your ongoing study demand.
Prancer RTSMⓇ Lite takes the manual processes out of managing a high volume of simple studies. With centralized reporting, improved accuracy and the ability to scale when you see promising results, this core version of our powerful randomization and trial supply management (RTSM) solution sets your clinical trials up for success.
Prancer RTSMⓇ supports everything from highly complex clinical trial designs to simple early phase trials and has the flexibility to scale your global supply strategy when the time is right. See how our leading Interactive Response Technology (IRT) solution can transform your next study.
Veeva SiteVault Free is a 21 CFR Part 11 and HIPAA compliant eRegulatory application used by more than 4,000 clinical research sites across over 75 countries. SiteVault Free replaces paper binders and manual processes and connects sites to over 400 sponsors using Veeva Clinical applications.
Take patient engagement to a whole new level with RealTime-TEXT. Improving patient retention while reducing no show rates will keep your research studies on track for success. Automated appointment reminders boost retention rates and enhance the patient experience.
Streamline your stipend payment process while providing your patients with a convenient payment card that’s easy to use.
Our industry-leading eRegulatory system, RealTime-eDOCS, is streamlining the way sites, sponsors and CROs manage regulatory documents electronically. Sites are now easily managing all of their study records while maintaining inspection readiness during the entire process.
RealTime is a proven leader of advanced research information systems. RealTime-eSOURCE is no exception as it was built and tested by research site professionals. Additionally, our eSOURCE has more features, greater scalability, better support, and all at an affordable price.
RealTime-CTMS is designed to provide quick and easy access to study or subject information utilizing simple and intuitive navigation. In most cases, needed information is only a few clicks away. RealTime-CTMS will guide you from study start-up to study close-out, and everything in between.
ConneX, the most personalized clinical trial travel solution, is designed specifically to meet the retention goals of global clinical trials. From simply setting up a ride, to full-service travel arrangements, ConneX provides peace of mind for patients, families, caregivers, sites, and sponsors.
Greenphire understands the complexities of clinical trial travel, whether by protocol, therapeutic area or region. ConneX can be configured to meet the diverse needs of each participant, eliminating logistical restrictions or limitations.
eClinicalGPS automates, streamlines, and accelerates global site payments, increasing overall site satisfaction. It also provides you with the cash flow transparency you need for more effective clinical trial forecasting, planning, tracking and quantitative assessment.
ClinCard allows you to reimburse and notify your patients instantly. It simplifies the clinical trial payment process and maximizes overall participant satisfaction, giving you more time to focus on your research. Using ClinCard instead of cash, money orders, rewards and other reimbursement methods has been proven to reduce patient drop out.
Research sites that use ClinCard see a cost and time savings within months of completing their implementation. ClinCard reduces administrative burden, eliminates errors and rework that come with manual processes and gives research team access to real-time, clean and accurate financial data for comprehensive reporting and visibility.
The ultimate investigator training and support system
As clinical trials become more complex, an increasing burden is being placed on investigators who have to deal with the frequent protocol amendments, more complex procedures and an ever expanding case report form. Ineffective training, inadequate communications and poor data capture methods contribute to poor trial performances which inevitably result in delayed recruitment, frequent non-compliances with protocols and ultimately, delayed study close-out and market approval.
Intuitive eSource for Optimal Site Efficiency
An effective eSource solution must be intuitive enough to effectively make clinical research easier. From the beginning, Clinical Ink’s SureSource® platform was designed for optimal site efficiency. Developed and tested with actual site users, SureSource is the only eSource solution designed to actually reduce site workload.
eSource Enabled Risk-Based Monitoring
In the face of increasing clinical trial costs, complexity and regulations, drug makers are under increasing pressure to save money while executing more efficient clinical trials. In an effort to enhance subject protection and clinical trial data quality, the Food and Drug Administration (FDA) issued final industry guidance in August 2013, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”.
In an effort to streamline and modernize clinical investigations, the U.S. Food and Drug Administration (FDA) in September 2013 issued final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.
Well-conducted Phase II clinical trials provide the data required to determine if there’s a case to be made for progressing a drug candidate into Phase III trials. However, Phase II success rates are lower than at any other phase of development. These larger late phase studies present unique challenges and even greater opportunities for the use of eSource to reduce costs and timelines.
The goal of early-phase clinical development – Phase I through IIa – is to test for the safety and efficacy of a drug candidate. In any disease state, conducting successful early phase trials is a key component of ushering a novel therapy through clinical development. Clinical Ink’s integrated SureSource® platform streamlines clinical development – from start to submit — to dramatically reduce R&D costs and project timelines while improving data quality and patient safety.
We provide technology solutions to align the best Research Sites with Sponsors and CROs to reduce drug development costs and cure disease.
Candidates: You need a partner in your job search who is dedicated to finding you the right opportunity to fit your skills and aspirations. Medix is committed to matching talent within the Healthcare, Scientific and Information Technology communities to achieve their professional goals.
In 2009, Medix’s Scientific Division was created to help teams in need find highly skilled and sought after talent in a wide range of scientific settings, including manufacturers, laboratories, biotechnology, pharma and medical device. As the numbers of registered clinical trials in America rose rapidly in the following years, Medix Clinical Research was founded in 2014 to service sites, sponsors and CROs of all shapes and sizes.
As our expertise expanded, so did our service offerings. In 2015, Medix Clinical Research introduced client consulting, bringing a more personalized approach to the site experience by providing expert guidance. Through our consulting efforts, our team identified an urgent need for standardized training processes across research sites in order to develop a qualified workforce, leading to the creation of the first-ever Clinical Research Boot Camp – facilitated by Medix and powered by ACRP. This one-of-a-kind approach combines Medix’s...
BlueCloud® Professional Directories are online permission-based, shareable regulatory and quality management systems designed for healthcare and clinical research organizations.
These collaborative directories allow organizations to maintain organized, verified professional, experience and training records (e.g., resumes, job descriptions, licenses, training, education and certifications documentation) between departments at the local level as required by regulatory agencies. Hospitals, universities, investigator sites, sponsors, institutional review boards, clinical research organizations, government and other management organizations can then securely exchange professional records using BlueCloud® Connection’s permission-based network.
BlueCloud®’s Purchasing Club offers discounts on thousands of products, services and specialties through a single-point ordering system via a collaborative network of healthcare and clinical research providers.
Training and educational products, discounted business-to-business (B2B) medical supplies, medical equipment, business and liability insurance and more are offered at pre-negotiated prices with discounts ranging from 10% to 80%.
TheBlueCloud® Education Network is a B2B global collaborative marketplace where private, shareable libraries of education, training and certification programs can be created and shared among healthcare professionals and other stakeholders. The Education Network is an invaluable resource for regulators, academia, authors, trainers, educators, consultants, trademark/copyright holders, publishing houses and accrediting agencies.
Simply view and choose subsidized and discounted training and educational programs from the most qualified providers around the world, including: NIH Stroke Scale, Rankin Scale mRS, Columbia Suicidality C-SSRS, Beck Depression Inventory®, Second Edition (BDI-II®), SCID, AIMS-BARS-mSAS-DISCUS, CDISC Standards, Multi-Therapy CME / CE Activities, Visual Health Information, Beckman Fugel Meyer Scale, VIP, POM, PASS, TUG, GCPs and many more.
The ideal distribution vehicle for authors and educators, minimizing fraud and abuse by allowing use...
Healthcare and research professionals can create their personal BlueCloud® accounts to track and “opt-In” to share their professional, experience and training (PET) records — such as resumes, licensure, certifications and training credentials — with network organizations.
The BlueCloud® even sends record expiration alerts to ensure compliance and track PET records 24/7.
BlueCloud® Clinical Trial e-Learning Management Systems save clinical researchers, sponsors, universities and educators thousands of dollars in technology development, management, customer support and administrative costs by allowing them to:
• develop evidence-based, private, protocol activities,
• manage users and control reporting online and off,
• develop, deliver and manage curricula, scales, modules, protocol changes on demand and
• automate version control challenges..
The BlueCloud® Continuing Medical Education (CME/CE) Management System saves accrediting providers hundreds of thousands of dollars in administrative, customer support, technology development and integration costs by allowing them to:
• develop, manage and track the complete CME/CE process on demand and
• track CE compliance assignments and information collected from accredited activities.
BlueCloud®’s Commercial e-Commerce Management System saves organizations thousands of dollars in bank fees and administrative, customer support, technology development, upgrades and integration costs.
Created specifically for industry providers, this application:
• delivers on-line products, services and specialties,
• collects transnational payments from sales of activities, created and published by BlueCloud® Education Network members,
• allows managers to create project bundles using on-line and enduring products, and
• offers discount packages using customized codes to help organize individualized strategic marketing campaigns.
BlueCloud®’s CustomsPoint is a patented import/export application that manages logistics for industry stakeholders when products are shipped transnationally.
A vital part of the supply-chain process, this application saves organizations millions of dollars when managing and tracking the customs compliance process from cradle to grave.
The BlueCloud® Staff Learning Management System documents and tracks healthcare education and training, allowing managers to:
• develop private, public or shareable activities,
• manage users,
• control reporting online and off,
• create, deliver and manage courses, modules, curricula, scales, questionnaires, standard operating procedures, protocol and project changes on demand,
• automate version control and
• track compliance challenges.
Generic modules also can be created for private use or to share with other departments.
BlueCloud® Staff Learning Management System is proven to save educators thousands of dollars in technology development, management, customer support and administrative and technology upgrades costs.
For healthcare and clinical research organizations, surveys are a vital part to providing valuable feedback directly from industry stakeholders. Asking the questions is the easy part. It’s getting the answers from busy healthcare professionals that is the challenge.
BlueCloud® Surveys are custom-designed questionnaires focusing on healthcare and clinical research organizations that help our industry analyze and improve products, services and specialties.
The BlueCloud® global network has close to a million members who are enthusiastic to complete online surveys, because they are incentivized for their participation. They can earn prizes and other rewards by completing surveys they are interested in, on their own time. BlueCloud® surveys help improve survey participation and your return on investment.
We have completed recruiting and retention campaigns for a wide variety of study indications that have reached males and females of all ages and races, including small demographic groups such as infants and children, adolescents and teens, adults, older adults and non-English speakers.
Used in conjunction with its study-specific websites, TPRA’s precise search engine marketing techniques are designed to generate additional traffic to its websites from potential qualified participants. This capability can be tailored to target specific geographical areas as well as a global reach.
Our IN-HOUSE media placement team carefully plans all media purchases, taking into consideration budgets, anticipated response rates, enrollment deadlines, risk factors and the anticipated ability to handle responses. Before developing and executing the placement strategy, we research the demographic profile of the indication and perform market research in each local market to choose the medium, format, publication and programs that will yield the greatest call response for the least cost.
Traditional Media:
Online Media and Marketing:
Mobile Outreach:
Our easy-to-use portal allows you to share documents with the entire study team. You and your team can upload and download study-related documents to be accessed in one secure location.
Our Communication Platform features three communication tools, and each tool is available with an imbedded response filtering system so that you will be able to expand your patient recruiting beyond the traditional means of marketing and response handling. Tools include Text Messaging, QR Codes™ marketing and Pre-screening Facebook pages. We also provide an administrative access point that includes all data in real-time.
Q-center™ is our pre-screening and scheduling service for Sponsors, CROs, SMOs and Investigators. These dynamic services offer a cost-effective and time-efficient alternative by eliminating the burden of call answering, pre-screening, scheduling and making appointment reminders. This will help maximize your ROI from all recruiting efforts.
TPRA’s production services also include designing and hosting full-featured, study-specific websites. These websites include Flash Video and either pre-screening or full screening questionnaires that offer multiple methods for the website visitor who passes the questionnaire to make contact with the study clinic.
Our technology platform, RADIUS365™, is the clinical research industry’s most powerful and comprehensive online platform of services and technologies for tracking, managing and reporting all recruiting efforts from the first call attempt to the last clinic visit.
Our experienced IN-HOUSE creative talent is supported with the latest technological tools available to produce highly effective and affordable site kit materials as well as TV, Radio and Print advertisements and the design and hosting of full-featured, study-specific websites.
