SYLOGENT EXHIBITS AT BIO IT
April 9-11, 2013
BOSTON, MA - Streamline Internal Processes, Maintain Compliance and Increase Audience Engagement in Speaker Programs
The 2013 Expo plans to unite 2,500+ life sciences, pharmaceutical, clinical, healthcare, and IT professionals from 30+ countries. The Expo provides the perfect venue to share information and discuss enabling technologies that are driving biomedical research and the drug development process.
Since its debut in 2002, the annual Bio-IT World Conference & Expo has established itself as a premier event showcasing the myriad applications of IT and informatics to biomedical research and the drug discovery enterprise. The 2013 program will feature compelling talks from industry and academia on new trends in data generation, knowledge management, and information technology in life sciences and drug development, including best practice case studies and joint partner presentations relevant to the technologies, research, and regulatory issues of life science, pharmaceutical, clinical and IT professionals. Bio-IT World Conference & Expo continues to expand with the addition of two new Tracks: Data Visualization and Clinical Omics.
SYLOGENT SPONSORS CLINTECH 2103
March 11-13, 2013
PHILADELPHIA, PA - Implement, Manage and Integrate Systems to Advance Clinical Trials
Whether you're responsible for CTMS, Portals, eTMF, EDC (or the entire eClinical suite), you can customize the agenda to suit your exact needs. With your busy schedule in mind, we've rolled four of our most popular clinical events into one comprehensive, flexible forum featuring highly sophisticated content, networking with more than 40 leading companies in the industry and over 50 expert speakers.
ClinTech 2013 is the only opportunity this year to learn more about the latest applications and operational strategies to meet the clinical demands of today, as well as gain insight on how to achieve platform and technology integration for the future.
Plus! The interactive Cloud Seminar examines the risk and rewards of hosting clinical data in the cloud. Discover the time, cost, storage and collaborative benefits of Cloud hosting in a seminar that answers industry’s most pressing questions.
SYLOGENT EXHIBITS AT DIA EUROPE
March 4-6, 2013
AMSTERDAM, NL - Strategic Publication Planning
Stakeholders and professionals of healthcare and life sciences innovation will gather from all over the world for the EuroMeeting 2013. You will experience a neutral, global forum for knowledge exchange that fosters innovation to raise the level of health and wellbeing worldwide. It is our vision that the EuroMeeting 2013 offers you a multidisciplinary, relevant and unforgettable learning experience and expands your personal and professional network.
With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the Euromeeting 2013 are classified into general disciplines including Pharmacovigilance and Regulatory Affairs for medicinal products and medical devices, R&D and Clinical Trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate.
The EuroMeeting 2013 transcends borders and boosts international relations by drawing attention to contemporary issues outside Europe such as in the USA, Brazil, China, Japan and India; and focusing on contemporary issues in the interface between those countries and Europe.
SYLOGENT SPONSORS SPEAKER PROGRAM MANAGEMENT
February 26-27, 2013
PHILADELPHIA, PA - Streamline Internal Processes, Maintain Compliance and Increase Audience Engagement in Speaker Programs
In its 5th year of production, CBI’s annual forum brings together experts in speaker program management to discuss compliant practices and innovative formats that are increasing the value and ROI of speaker programs across industry. In an era of evolving regulations and new technology it is imperative for individuals involved in the management of speaker bureaus to keep a pulse on new technology and recent regulations affecting the quality of programs today.
Address off-label discussions
Calculate for ROI for speaker programs
Examine non-branded speaker programs
Determine FMV for HCPs
Cutting edge technology to support programs
SYLOGENT SPONSORS TIPPA PUBLICATION PLANNING
February 11-12, 2013
LOS ANGELES, CA - International Publication Planning 11th Annual Meeting
For the1th straight year, this conference brings together leaders in medical publishing to discuss best practices for successful strategic publication planning. Transparency has never been more demanding and this conference continues to keep all publication planning teams up to speed on how their policies align with the changing external environment. Attend this conference to understand how evolving regulations, new media considerations and the global industry climate impact your publication planning initiatives.
Demands of increased transparency
Use of new technology in disseminating information
Navigating processes under a CIA
Assessing the value of publications
Integrating health outcomes into pub planning
Strategies for global planning
SYLOGENT EXHIBITS AT ISMPP EUROPE
January 22-23, 2013
LONDON, UK - ISMPP EUROPE
It is with immense pleasure that isMPP opens registration for the 2013 European Meeting, ‘Doing the right thing anD Doing things right.’
it is increasingly important that as medical publication professionals we not only work within current guidelines but also strive to improve the regulatory framework to ensure that the industry’s reputation for ‘doing the right thing’ continues to improve.
The five main sessions of the european meeting will address many of the key challenges we face as medical publication professionals and provide practical solutions to help ensure that we are ‘doing things right’ on a day-to-day basis:
a review of global insights and trends from 2012 and how these will impact our profession in the year ahead;
an opportunity to discuss best practices in compliance and tackle some of the difficult questions that we regularly face;
an insight into the role of payors and what they need in terms of an evidence base to help them in their decision making;
a chance to meet editors from a variety of journals and have informal discussions with them on a range of topics;
a thought-provoking view of how bright the future is for the medical publication profession
Strategies for global planning
SYLOGENT SPONSORS STRATEGIC PUBLICATION PLANNING FORUM
December 12-12, 2012
PHILADELPHIA, PA - Strategic Publication Planning
For the 8th straight year, this conference brings together leaders in medical publishing to discuss best practices for successful strategic publication planning. Transparency has never been more demanding and this conference continues to keep all publication planning teams up to speed on how their policies align with the changing external environment. Attend this conference to understand how evolving regulations, new media considerations and the global industry climate impact your publication planning initiatives.
Demands of increased transparency
Use of new technology in disseminating information
Navigating processes under a CIA
Assessing the value of publications
Integrating health outcomes into pub planning
Strategies for global planning
SYLOGENT SPONSORS CLINICAL TRIALS REGISTRIES CONFERENCE
November 20-21, 2012
LONDON, ENGLAND - Clinical Trial Registries Conference
Transparency of information in ongoing and completed clinical trials is an established expectation of society reinforced by regulation and by codes of practice in many parts of the world. It is a necessary pillar to ensure public trust in the clinical trial process and the evaluation of clinical trial outcomes. Discussion is now focused on the different mechanisms for transparency, their scope, objectives and audience. This increased transparency changes the landscape of availability and use of information from clinical trials, and brings with it new opportunities and challenges.
Clinical trial registries - Overview of current worldwide situation: EU, USA, Germany, Italy, and other countries
Impact of changing international legislation on journal editors and publication issues
Initiatives to standardize data requirements of clinical trial registries and results databases to facilitate reproducibility and data querying
Challenges faced by academia with moving regulatory targets and emergence of new registries/results databases
Operational and technical implementation of automating processes and streamlining data transfer for clinical trial disclosure
Access and data use of clinical trial protocol/results information by patients, informatics organizations, third-party payers, and others
“State of the nation” of ClinicalTrials.gov and EU CTR
SYLOGENT SPONSORS COMMERCIAL MASTER DATA MANAGEMENT AND PROCESS IMPROVEMENT CONFERENCE
November 8-9, 2012
PHILADELPHIA, PA - Life Sciences Forum on Commercial Master Data Management and Process Improvement
As regulations continue to increase surrounding the aggregation and reporting of data, companies are continuing to look for ways to standardize, or at the very least, sync up data across various systems. The ability to capture, store, search and share data is critical to the Life Sciences industry. This is particularly true for commercial data which is reliant on dependable, credible and up-to-date data. As the need for creating a reliable enterprise view of the customer continues to increase, so does the expansion of Commercial Master Data Management (MDM). Attend this forum and hear strategies for deploying or enhancing a customer master to meet internal and external requirements.
The impact of Big Data on Commercial MDM
Securing and accessing customer data in a timely fashion
Developing a repository of practices to govern data collection, processing, quality assurance, distribution and consumption
Extracting (and cleansing) master data from internal and external 3rd party transaction data
Bridging the gap between marketing and data analytics
Collectively working through country specific regulations
Foundational tools to enhance an enterprise wide customer MDM
SYLOGENT SPONSORS EU PHARMACOVIGILANCE FORUM
October 23, 2012
PHILADELPHIA, PA - Forum on the New EU Pharmacovigilance Legislation
The European regulatory agency (EMA) released new draft pharmacovigilance legislation on February 22, 2012, with the guidelines officially going into effect on July 2, 2012. These guidelines will have serious implications for the global pharmaceutical industry, particularly a significant increase in the workload within PV departments. Some of the changes include:
Creation of a new Pharmacovigilance System Master File (PSMF)
New responsibilities for signal detection and statistical reports
Direct patient reporting of adverse events to national medicines authority
Different PSUR templates
Noted as one of the largest transformations covering PV within the last ten years, the EU legislation must be better understood by pharmaceutical companies operating globally. The purpose of CBI’s Forum on the New EU Pharmacovigilance Legislation is to provide concrete guidance on the following timely topics:
Align company processes with the new regulations
Harmonize EU and U.S. safety reports
Ensure compliance with new legislation to improve patient safety
The use of large external databases for safety signals and evaluations
SYLOGENT LAUNCHES PROSTRAT TO STREAMLINE PUBLICATIONS, NON-PROMOTIONAL AND PROMOTIONAL APPROVALS
September 12, 2012
NEWTOWN, PA--(Marketwire - Sep 12, 2012) - - Sylogent today announced the launch of ProSTRAT, a new internet-based application that streamlines the way that pharmaceutical companies move documents through their approval process.
"Our experience revealed that major pharmaceutical companies typically route proprietary information through a mixture of home-grown systems, off-line conversations and random emails," stated Jack Yeager, CEO of Sylogent. "This creates the bad combination of a high-risk task and inefficient process, which is easily solved with our technology."
ProSTRAT organizes and standardizes the process by enabling any individual to upload a document into the system, which is then automatically assigned to the appropriate stakeholders. "This web-based tool is ideal for any company that must protect their proprietary information while adhering to numerous compliance regulations without overburdening their employees," stated Yeager.
ProSTRAT integrates with Sylogent's industry-leading Journal Selector and Conference Authority databases, along with a newly revamped Cite Central Repository, providing companies with a complete system from target selection through approval tracking to document storage.
Sylogent has extensive experience in data aggregation, workflow automation, and document management gained through its other applications, which are currently deployed at leading pharmaceutical companies and include PubSTRAT, VCTR, SylogiQ, and SytriQs.
"Our mission is to drive compliance and minimize employee workload while saving our clients millions of dollars in unnecessary costs," said Yeager. The company already has deployed the ProSTRAT application at one major pharmaceutical company and expects to complete deployment at another within thirty days.
Sylogent provides software solutions to the pharmaceutical, biotech and medical device industries. The company focuses on innovative internet-based applications that automate and simplify core business processes.
MarketWire Press Release
SYLOGENT SPONSORS MEDICAL COMMUNICATIONS SUMMIT
September 20-21, 2012
SAN DIEGO, CA - Pharmaceutical medical affairs teams; Overcome unclear standards for transparency and regulatory compliance to deliver impactful scientific information!
CBI's Medical Affairs and Communications Summit-delivers best practices and SOPs vital to the compliant, accurate and impactful delivery of medical-information. Attend the 2012 event and benefit from:
Knowing the latest in CIAs and how these agreements impact HCP interactions
Understanding how litigation trends and the Sunshine Act impact medical communications
Compliantly connecting with patients and healthcare providers through social media, apps and the web
Identifying strategies to create parallel strategies across medical and commercial groups
Best practices for disseminating comparative effectiveness information in publications and in the field
SYLOGENT SPONSORS TIPPA PUBLICATIONS PLANNING EVENT
July 23-24, 2012
CHICAGO, IL - Join us in windy Chicago July 23-24 to hear top experts in the industry discuss the hottest issues effecting pharmaceutical publication planning today. TIPPA's 10th Annual Meeting provides a forum for pharmaceutical communications professionals to discuss the current changes and challenges affecting publication planning, while promoting lively and constructive discourse from multiple perspectives.
Develop a clear understanding of the upcoming Sunshine Act of 2012 and how it will affect publication planning
Learn to construct effective rubrics for drafting equitable authorship agreements and other types of contracts
Devise systems that foster positive and productive relationships throughout the publication process
Hear how companies are accomplishing the day-to-day tasks required under a CIA
Gain an understanding of how to handle journal retractions; and how to avoid them
SYLOGENT EXHIBITS AT DIA ANNUAL MEETING
June 25-27, 2012
PHILADELPHIA, PA - The DIA 2012 Annual Meeting features 280+ sessions across 22 tracks, including comprehensive coverage of today's hottest topics, such as:
Cloud Computing
Emerging Markets
EMR/EHR (Electronic Medical Record/Electronic Health Record)
Epidemiology
eSource
Investigative Sites
IRB's Institutional Review Boards
Partnering Models-Public Private Partnerships
Patient Recruitment
Patient-reported Outcomes
Personalized Medicines
Postmarketing Activities
Social Media
Source Document Verification
Special Populations
Study Endpoints
Supply Chain Management
Virtual Clinical Trials
Warning Letters and Audits
SYLOGENT SPONSORS ISMPP ANNUAL MEETING
June 11-12, 2012
AMSTERDAM, NETHERLANDS - The relationship between journal publications and trial databases is essential for full disclosure of clinical results information to the public. The challenge is that it takes longer for information to be published in an article, so there may be discrepancies between the primary results specified in registries and the information specified later in a publication. The question is – how do you coordinate the information that is posted in both areas to ensure data transparency?
This conference is unique because it incorporates information from both the publication side and clinical trial registry side to educate pharma companies about best practices of integrating and coordinating both areas globally.
SYLOGENT SPONSORS CLINICAL TRIAL MANAGEMENT FORUM
May 15-16, 2012
PHILADELPHIA, PA - Benchmark against the best minds in clinical finance and project management!
Hundreds of stakeholders critical to the planning, forecasting and management of clinical trials united to share best practices and compelling case studies and participated in thought provoking discussions. After an incredibly successful first year, Clinical Trial Budgeting and Project Management East is resuming in 2012. This event is the perfect opportunity to gain the tools needed to accurately forecast and plan clinical trials for better budget and timeline management.
Sessions in development include:
Identifying the unique components of pharmacovigilance and post-approval trials
Technology to streamline and manage multiple trials
Planning and executing timely and in-budget trials in emerging markets
Budgeting and managing adaptive trials
SYLOGENT EXHIBITS AT BIO-IT WORLD EXPO
April 23-25, 2012
BOSTON, MA - Since its debut in 2002, the annual Bio-IT World Conference & Expo has established itself as a premier event showcasing the myriad applications of IT and informatics to biomedical research and the drug discovery enterprise. The 2013 program will feature compelling talks from industry and academia on new trends in data generation, knowledge management, and information technology in life sciences and drug development, including best practice case studies and joint partner presentations relevant to the technologies, research, and regulatory issues of life science, pharmaceutical, clinical and IT professionals. Bio-IT World Conference & Expo continues to expand with the addition of two new Tracks: Data Visualization and Clinical Omics.
SYLOGENT SPONSORS ISMPP ANNUAL MEETING
April 23-25, 2012
BALTIMORE, MD - The complexities of the medical publications arena continue to grow—more guidelines, increased restrictions, enhanced requirements, and less resource. All of these elements converge to make an already-complex profession even more so. Navigating through theses complexities requires not only a well-grounded understanding of what they are, but also practical approaches to problem solving to achieve our collective end goal—the dissemination of clinical-trial-associated data that will support clinical decision-making.
The 8th Annual Meeting of ISMPP, Practical Solutions for a Complex Medical Publications World, is designed to highlight the key challenges we are facing, and provide practical solutions to help resolve issues and manage processes while operating within the realm of best practices in an especially cost-conscious environment.
SYLOGENT SPONSORS CLINICAL TRIAL REGISTRIES FORUM
April 24-25, 2012
PHILADELPHIA, PA - With the proliferation of multiple registries and increased call for transparency, the life sciences industry continues to face challenges in staying abreast of current clinical data disclosure requirements. For the past six years, attendees have collaboratively discussed the latest global regulations for data disclosure and reviewed how this information is being used and by whom. Network and share best practices for managing the ever-growing demands for clinical data registries and results databases.
SYLOGENT SPONSORS CLINICAL STUDY START UP FORUM
April 10-11, 2012
This forum convenes clinical professionals involved in site selection and initiation and study activation. Examine global and U.S.-specific challenges in data acquisition and management as well as communications with regulatory bodies. Explore initiatives to streamline processes and reduce timelines.
SYLOGENT SPONSORS CLINICAL TRIAL MANAGEMENT SYSTEMS FORUM
March 22-23, 2012
PHILADELPHIA, PA - Are you interested in learning more about the CTMS options available? Looking for best practices for initial implementation and end-user training? Or seeking to benchmark against the industry to optimize the system you have? We've designed a track specifically to meet your needs. CBI’s 5th Clinical Trial Management Systems is the must-attend event for clinical business and IT professionals to come together to learn from the challenges and successes of their industry counterparts. This meeting addresses topics ranging from regulatory and reporting requirements to building a quality strategy and system integration strategies.
SYLOGENT EXHIBITS AT CLINICAL TRIALS PARTNERS
March 5-7, 2012
ORLANDO, FL - The world has radically changed in just the last few years and the trend is likely to continue at an exponential rate. Partnerships in Clinical Trials is changing with it. Partnerships has always been where business gets done and strategic partnership deals are inked, but in 2012 it is where the industry moves forward with answers. We've taken your most pressing challenges and translated them into the most provocative meeting agenda the industry has ever seen.
Are you empowered to revolutionize the future of clinical trials?
Are you expertly managing the rigorous demands of complex global clinical trials?
Are you prepared for the single most important new technology that will change the clinical trial arena forever?
Are you quickly adapting your clinical development model to support targeted therapeutics?
Are you and your CRO aligned as true partners to share risk and innovate to significantly improve success rates for clinical trials?
SYLOGENT SPONSORS TIPPA ANNUAL MEETING - PUBS PLANNING
February 15-16, 2012
SAN DIEGO, CA - Join us in sunny San Diego February 15th & 16th to hear top experts in the industry discuss the hottest issues effecting pharmaceutical publication planning today. TIPPA's 10th Annual Meeting provides a forum for pharmaceutical communications professionals to discuss the current changes and challenges affecting publication planning, while promoting lively and constructive discourse from multiple perspectives.
Develop a clear understanding of the upcoming Sunshine Act of 2012 and how it will affect publication planning
Learn to construct effective rubrics for drafting equitable authorship agreements and other types of contracts
Devise systems that foster positive and productive relationships throughout the publication process
Hear how companies are accomplishing the day-to-day tasks required under a CIA
Gain an understanding of how to handle journal retractions; and how to avoid them
Plus More !
SYLOGENT SPONSORS SPEAKER MANAGEMENT FORUM
February 23-24, 2012
PHILADELPHIA, PA - The implications of Healthcare Reform are still changing the way pharmaceutical and medical device companies are managing and monitoring their speaker bureaus:
This forum brings together experts in speaker program management to discuss compliant practices and innovative formats that are increasing the value and ROI of speaker programs within their organizations.
SYLOGENT SPONSORS KNOWLEDGE MANAGEMENT FORUM
January 23-24, 2012
PHILADELPHIA, PA - In medical affairs, effectively managing internal medical information and capturing new knowledge from the field is essential. The benefits of knowledge management can be seen across all departments and these efforts increase productivity exponentially. Hear strategies to implement a KM initiative and how it can help you compliantly manage and share knowledge. Through case studies and thought-provoking panels, discuss knowledge management from the first step to the end result and understand how to create a culture of knowledge.
SYLOGENT ACQUIRES CROSS DEVICE VIDEO PLAYER
NOVEMBER 30, 2011 - MARKETWIRE
NEWTOWN, PA--(Marketwire - Nov 30, 2011) - Sylogent today announced that it acquired the assets of SonicPlayer, LLC, specifically its cross-device media player that broadcasts video across any mobile device or computer at scheduled times. The company is in the process of enhancing the system to assist pharmaceutical companies that need to deliver key communications to select individuals.
"Pharmaceutical companies need help communicating directly with medical professionals in an affordable and secure manner. Face-to-face opportunities such as dinners, office visits or other personal events are too expensive and have fallen out of favor for a variety of reasons," stated Jack Yeager, CEO of Sylogent. "Budgets have been dramatically cut, but it remains critical for medical professionals to receive information from drug and device manufacturers. Our solution utilizes scheduled video broadcasts that play on smartphones, tablets or computers."
"The enhanced solution, to be called MedCast, will also include tools that permit presenter and participant interaction, the ability to complete surveys, and functionality that will permit doctors to order samples or other materials during or after the video," stated Yeager. "Sylogent has extensive experience and technology to offer clinical development teams, and this acquisition expands our solutions into the sales and marketing side of the business."
Sylogent's vision with its cross-device media player MedCast is to provide its clients with an affordable yet effective communication solution. MedCast will provide a 24/7 communication platform that can be viewed on any computer or device (iPhone, Android, iPad) by any professional with cellular or internet access.
MedCast represents Sylogent's first technology solution aimed at the brand, marketing and sales groups. The system is expected to launch in the first quarter of 2012. "Our goal is to drive effective, convenient and secure communications at the lowest price possible," said Yeager.
Sylogent provides software solutions to the pharmaceutical and medical device industries. We create value by automating core processes thereby saving our clients millions of dollars through better compliance, improved efficiencies and lower technology costs.
MarketWire Press Release
SYLOGENT LAUNCHES PHARMA APPROVALS MODULE
NOVEMBER 10, 2011 - MARKETWIRE
NEWTOWN, PA--(Marketwire - Nov 10, 2011) - Sylogent today announced that it completed development on its Approvals Module and the company expects to deploy the system for several clients by year's end.
"Biopharma and device company SOPs typically require an extensive approval process before clinical data, documents or other materials can be disclosed," stated Jack Yeager, CEO of Sylogent. "In talking with our industry contacts, we understand that the approval process typically is managed by using a home-grown system, an offline committee, or requires executive approvers to learn multiple systems to manage a piecemeal approvals process."
"We have identified an increasing demand for a single, simple, disclosure approvals system," stated Yeager. "Sylogent has extensive experience in managing approvals processes that we gained through our PubSTRAT, VCTR, ReCAP, and Publish II solutions currently active in a wide range of customers."
With the Approvals Module Sylogent envisions a configurable solution that will centralize and streamline the enterprise approvals processes in research, clinical development and publication planning. The Approvals Module will offer direct entry for new approval requests, but also can receive requests routed from third-party applications.
The Approvals Module represents the first module in Sylogent's new SylogIQ Platform that aims to organize, standardize and automate the clinical development process for our customers. "Our goal is to drive compliance, maximize efficiencies and dramatically reduce operating costs. We aim to save our customers millions of dollars," said Yeager.
"As we work with our customers' data, we've become aware of a growing need for standardized data and metadata in clinical development systems, to reduce re-keying or data migration workloads as data are moved from protocol to trial registration to results reporting to publications, with all the many steps in between," stated Yeager.
Sylogent provides software solutions to the pharmaceutical and medical device industries. We create value by automating core processes thereby saving our clients millions of dollars through better compliance, improved efficiencies and lower technology costs.
MarketWire Press Release
SYLOGENT EXHIBITS AT DIA ANNUAL MEETING
JUNE 19-22, 2011 - booth 2053
Sylogent will exhibit at the 2011 Drug Information Association Annual Meeting June 19-22 in Chicago, IL. The company will feature demonstrations of its new Clinical Development Management System, SylogIQ.
Sylogent provides software solutions to the pharmaceutical and medical device industries. We create value by automating core processes thereby saving our clients millions of dollars through better compliance, improved efficiencies and lower technology costs.
SYLOGENT SPONSORS ISMPP 7th ANNUAL MEETING
April 4-6, 2011
The International Society for Medical Publication Professionals (ISMPP)
is pleased to announce the opening of registration for its 6th annual
meeting, “Delivering Value and Driving Advocacy in Medical
Publications.” The meeting will run from April 19 to 21, 2010, in
Arlington, VA, at the Crystal Gateway Marriott.
ISMPP has created an exciting program that focuses on two of the most
critical factors that are relevant to all who work in medical
publications — value and advocacy. Both are integral to ensuring that
medical publication professionals can continue to contribute to the
dissemination of the results of clinical trials with accuracy,
transparency, and integrity.
To address these issues, this year’s plenary sessions will explore such
topics as the impact of guidelines and regulations, including GPP-2;
ISMPP’s advocacy activities; and insights of journal editors. Unique
this year to the journal editors’ segment is the rollout of an authors’
tool kit that has been developed by editors of top-tier medical
journals. As in the past, the meeting will also offer half-day pre- and
post-conference workshops and original ISMPP member research
presentations.
SYLOGENT SPONSORS WEBINAR WITH CBI
FEBRUARY 24th 11:00am EST - The Perfect Storm: Conflicts Arising from Clinical Data Disclosure and Publication Planning
Wherever you look there is evidence of a growing storm of activity
around clinical trial registration and results disclosure (CTRR). This
mandatory registration for most protocols and full disclosure of trial
result summaries within a year of primary (outcome) completion date has
significant implications for publication planning professionals.
This webinar will examine current state of CTRR from its epicenter to
its ever-expanding margins. It will then walk delegates through the
implications for publication professionals and suggest practical
strategies to help insure that your primary journal publication is timed
as close as possible to your result disclosure.
Key Learning Points:
- What regulations and guidances are in place today that mandate CTRR?
- What new CTRR regulations and guidances are expected in the short term?
- What are the main implications of CTRR for trial sponsors?
- How does this impact publication planning teams?
- How are successful publication teams evolving their processes to adapt to these important environmental changes?
SYLOGENT SPONSORS DISCLOSURE CONFERENCE
April 27-28, 2011 Philadelphia, PA
CBI’s 6th Forum on Clinical Trial Registries and Results Databases - Over the last several years, the global regulatory framework for
clinical trial transparency has evolved considerably. With rule-making
expected domestically, the highly anticipated release of EudraCT Version
8 and the continued proliferation of national registries around the
globe all planned for 2010, this trend is sure to continue.
In order to remain compliant, those charged with trial registration and
results disclosure must capitalize on valuable opportunities to interact
with likeminded professionals and develop best practices for a global
compliance program.
As one of the industry’s most revered forums since 2006, CBI’s 6th
Clinical Trial Registries and Results Databases Conference boasts the
perfect mix of topics in 2011.
In addition to expert perspectives from U.S. and European based
speakers, the program also features representatives from national
registries such as Chile, India and the Netherlands. Register today and
don’t miss your only opportunity to obtain essential information
directly from the source!
SYLOGENT SPONSORS CLINICAL DATA DISCLOSURE CONFERENCE
January 12-13, Washington, DC - EXL 5TH CLINICAL DATA DISCLOSURE CONFERENCE
Beginning in 2007, the Food and Drug Administration Act (FDAAA) required
drug and device companies to register their investigational studies in
clinical trial databases. FDAAA stated that Clinicaltrials.gov was the
repository that must be used and required the registration of new
clinical studies and the disclosure of results for completed studies.
The principle behind clinical trial reporting is to increase
transparency into the drug and device development process, and by doing
so, alleviate any doubts the public may have about the conduct of
clinical trials, and safety of drug and device companies’ products.
In recent years, the industry has encouraged greater transparency in the
drug and device development process. New laws and guidances from
regulatory agencies and health organizations require that drug and
device companies provide transparency into their clinical studies.
Clinical disclosure is becoming increasingly crucial and is a necessity
for companies to understand and comply.
We hope you can join us for this valuable educational and networking opportunity.
Read More
SYLOGENT RELEASES CLINICAL REGISTRY SOLUTION
NOVEMBER 1, 2010
Sylogent today announced the release of the 2.1 version of its Clinical Trial Registration and Results Disclosure solution, VCTR (Victor).
"Current customers are anticipating significant savings in cost and time, as well as improvements in data accuracy, as a result of this release," stated Jack Yeager, CEO of Sylogent. "Exporting data from SAS and importing it into VCTR will mean that customers will no longer be relying on expensive and frequently overstretched professionals to manually enter this complex dataset."
Industry statistics indicate that manual data entry into the FDAAA format can take between 20 and 40 hours and often requires significant input from highly compensated resources such as biostatisticians.
"Part of the challenge sponsors face is that SAS only offers limited export to XML capabilities, requiring subsequent transformation into FDAAA format," stated Yeager. "We solved this problem by developing a proprietary flat file data format so that customers can get data out of SAS quickly and easily, and then import it into VCTR with just a few clicks. Once in VCTR, data is transformed into FDAAA format, validated, and ultimately routed through configurable review and approval processes prior to posting to the registries."
Sylogent provides customers with the option to import any individual FDAAA result section (such as Adverse Events), or all major data-intensive sections, offering up to 90% of data entry automation.
The company worked closely with SAS programming teams from two leading pharmaceutical customers to perfect the schemas and data import process, which was extensively tested prior to production launch.
"We focus on delivering the best service, solutions and value for our clinical data disclosure customers," stated Yeager.
MarketWire Press Release
SYLOGENT COMPLETES ACQUISITION OF PEERVIEW
July 14, 2009
Sylogent today announced that it has completed its acquisition of PeerView, Inc. This asset acquisition agreement brings to Sylogent the market-leading publication planning solutions PubSTRAT™ and the innovative VCTR™ clinical registry solution.
As a result of the transaction Sylogent has relocated its headquarters to the historic Stocking Works in Newtown, PA, and will maintain its satellite office in Somerville, MA. Most key PeerView staff joined Sylogent, thus ensuring minimal disruption to the broad and long-standing customer relationships.
The PubSTRAT™ Web Suite™, comprising Conference Authority™, Journal Selector™, PubSTRAT™, and PubSTRAT™ CiteCentral™ is a leading publication planning solution that is in regular use by a growing number of customers in the pharmaceutical and biotech industries.
VCTR™ is rapidly emerging as the leading platform to support compliance with the increasingly complex clinical data disclosure process for biotech and pharmaceutical companies. Clinical data disclosure includes the timely registration and updating of clinical trials information as well as the posting of trial results to publicly accessible websites. The VCTR platform enables customers to significantly reduce the burden of maintaining large and complex clinical development programs in full compliance with the ever-changing US and International regulations.
“We are excited to welcome our new colleagues to Sylogent and to bring add the PeerView products and services to our offerings,” stated Jack Yeager, CEO and Founder of Sylogent. He continued, “The addition of PeerView is seen as critical to the planned growth of Sylogent, both organically and through strategic acquisitions.”
Sylogent is focused on providing workflow solutions and services that support the late clinical development and early commercialization business processes of our pharmaceutical and biotech customers.