What We Do
Syntactx provides a variety of services tailored to meet the specific needs of our clients. We take clinical trials from product inception through market introduction and post-market studies.
In addition to our in-house team, Syntactx’s strategic partners include clinicians, academic and non-academic institutions, and regulatory agencies with whom we work on a regular basis to develop, execute, and deliver the highest quality clinical trials.
At the root of every successful Clinical Trial is a well-developed Study Protocol.
Syntactx has in-house expertise to assist the client with development of protocols for all phases of human clinical trials from First-in-Man to Post-Market Approval Studies. Medical writers team with in-house physicians, biostatisticians, and external key opinion leaders to produce an investigational plan that accomplishes the goals of the client with efficiencies in cost, time, and execution.
Working with the FDA and other agencies around the world, Syntactx helps clients navigate through the stringent requirements to gain regulatory approval.
In addition to regulatory submissions, we identify and report any issues in an accurate and timely manner to avoid potential setbacks. Our team knows what elements are needed for submission and can anticipate potential questions or obstacles. Ultimately, we determine the fastest and most efficient route to regulatory approval, thereby enabling our clients to introduce products into the marketplace as quickly as possible.
- Preparation for Institutional Review Board (IRB) submission, central IRB management, consultation on local and central IRB related matters, and management of clinical trial websites such as ClinicalTrials.gov;
- Preparation of regulatory authority submissions including IND/IDE clinical trial submissions, clinical trial applications, and report management services such as primary endpoint and periodic reports;
- Strategic planning, product life-cycle management, and investigator compensation.
Clinical Project Management
Paramount to optimal Clinical Project Management is having a seasoned team that understands how to handle all of the elements involved in meeting the varied needs of study Sponsors, Investigators, site research staff, and study subjects.
Our Clinical Project Management Team oversees project execution throughout the entire study lifecycle to ensure that critical milestones are met on time. In addition, throughout the conduct of a study, our team continuously implements process improvement and an effective communication strategy.
Clinical Project Management services include:
- Site identification and qualification;
- Investigator identification, qualification, and recruitment;
- Site start-up;
- Ensuring site regulatory compliance;
- Facilitation of clinical trial enrollment;
- On-site and in-house monitoring, coordination of monitors, and data collection;
- Monitoring of CRF completion, data collection, and query resolution;
- Adverse-event reporting and medical coding;
- Study payment distribution and tracking;
- Remote monitoring in U.S. and Europe;
- Site close-out.
Syntactx works closely with key opinion leaders globally to maintain the integrity and overall conduct of all clinical trials.
We ensure study credibility, trial participant safety, and protect Sponsor interests. Our in-house Safety team has extensive knowledge of how to conduct studies, evaluate Safety endpoints, and determine adverse event issues and severity.
When necessary, we assemble and manage the appropriate Clinical Events Committee and Data Safety Monitoring Board. Syntactx has developed strong relationships with a large network of world-class physician consultants with clinical research expertise for our Sponsor clients to tap into.
Clinical Events Committee (CEC) & Adverse Event Reporting
Syntactx takes full responsibility for the creation and management of the CEC, which is central to establish standardized, reliable reporting of trial data.
Our CECs are comprised of top-level professionals who work in conjunction with our team to ensure accurate and timely reporting and classification of adverse events.
Using MedDRA certified coders and a Part 11 compliant database, Syntactx performs appropriate coding of adverse events, collects and collates source documentation, translates source documents as needed, and reports any adverse events in a timely manner to the study Sponsor and other appropriate parties. A clinical endpoint adjudication system provides an electronic method to manage Safety events.
Data Safety Monitoring Board (DSMB)
The safety of study participants is the highest priority of any clinical trial. As with the CEC, Syntactx assists in organizing and managing a DSMB to protect participant safety and ensure the credibility of the study results.
A DSMB is comprised of individuals with relevant clinical experience, previous DSMB/CEC experience, and no conflicts of interest. Collectively, we safeguard the interests of the Sponsor and ensure the safety of study participants. Our team works with the DSMB to review of Safety data and make thoughtful, data-driven recommendations to continue, modify, or terminate the study.
Additional Safety management services include:
- MedDRA Coding: Coding adverse events using the latest version of the MedDRA dictionary;
- CM Coding (medication): Coding drugs using WHO ATC Drug Dictionary;
- Independent Clinical Event Review: Physician assessment of Safety endpoints, and Medical Monitoring – physician oversight of study conduct.
Proper data management is critical to the success of a clinical trial, and our services consistently lead to the collection of reliable, statistically sound data for our clients.
Our data management services support the clinical research process and provide data in customized, client-specific structures and formats that integrate data from Core Laboratories, event committees, and patient reports.
As the scientific and regulatory requirements increase the complexities of today’s clinical trials, Syntactx works to procure and manage the appropriate data systems to provide reliable, accurate, and timely results.
Data Management services include:
- Paper and electronic database development;
- Electronic Data Capture (EDC) support:
- Custom database design;
- Database programming;
- 21 CFR part 11 compliant validation.
- Monitoring of case report form completion, data collection, and query resolution;
- Interim data analysis and study status reporting;
- Medical writing of manuscripts for peer-reviewed journals;
- Abstracts and presentations for scientific meetings;
- Final data analysis and reporting.
The Syntactx Core Laboratory works with advanced technology and an experienced and knowledgeable staff to produce precise and top tier results for our clients.
A study site-friendly image transfer process and standardized, reproducible results are critical aspects of our Core Laboratory operation. We constantly monitor the performance of our image readers in order to generate the most accurate and consistent results possible.
Our Core Laboratory analysis encompasses a variety of modalities including arteriography/venography, pulmonary angiography/venography, echocardiography and cardiac CT, CT angiography of the aorta, and head CT/MR. These services are currently provided for a spectrum of needs ranging from investigational studies to Pre- and Post-Market Approval Studies. Additionally, Syntactx utilizes web-based, secure image transfer technologies and 3D rendering software to ensure that our laboratory remains on the cutting edge.
Our network of skilled image readers, in-house physicians, and a broad reach to key opinion leaders make the Syntactx Core Laboratory a pioneer in the image review arena.
Electronic Data Capture
In a constantly modernizing clinical research industry, electronic data capture systems can increase the accuracy of data collection and decrease the time it takes to collect this data.
For the most sophisticated level of efficiency and accuracy in collecting, tracking, and storing clinical trial data, Syntactx has a proprietary, customizable, and fully secure cloud-based system to house data for both small- and large-scale trials.
- Multiple tiers of redundancy to protect confidential data;
- 21 CFR Part 11 Compliant digital touch screen signature capabilities for straightforward use among subject population to streamline a proprietary electronic consenting process;
- Blinded data to maintain HIPAA compliance;
- Hard and soft edit checks;
- Site, study-wide, and patient summary dashboards;
- Highly secure cloud servers and web portal entry.
We also offer personalized, dymanic context electronic case report forms and customized data reporting with CSV exports. Data may also be presented in intuitive dashboards. Workflow is designed to improve Protocol adherence while maintaining a user-friendly experience. In addition, with encrypted API or sFTP, data can easily be transferred to clients on an as-needed basis to track trial progress.
Published medical writing is a highly effective marketing tool and provides the opportunity to share ideas with professionals around the world.
Syntactx offers full-service, high-quality medical writing services that include content concept, copywriting, copyediting, biostatistics and graphics, and publication submissions. In addition to these services, the Syntactx medical writing team performs structed literature searches and reviews.
At Syntactx, our team of expert writers covers regulatory submissions, study Protocols, clinical evaluation reports, clinical investigational Protocols, investigator brochures, clinical study reports, abstracts and presentations for scientific meetings, and manuscripts for leading academic peer-reviewed journals.
Using our extensive experience and insight, we help clients develop a strategy that targets the most suitable publications and follows the standards of the International Society for Medical Publication Professionals and Good Publication Practice guidelines for journal authorship. We collaborate with well-regarded physicians that are experts in subject matter for either lead or co-authorship, and tailor manuscript submissions to meet the requirements of leading journals.
Our team is made up of in-house and contracted writers. We have excellent, long-standing relationships with leading experts across a multitude of therapeutic areas. Collectively, these physicians have published hundreds of papers in the most well-respected and highest impact journals.
List of Publications
Ouriel, K., R. L. Ouriel, Y. J. Lim, G. Piazza and S. Z. Goldhaber (2017). "Computed tomography angiography with pulmonary artery thrombus burden and right-to-left ventricular diameter ratio after pulmonary embolism." Vascular 25(1): 54-62.
Ross, J. R., D. L. Franga, M. Gallichio, A. J. Patel and K. Ouriel (2017). "Role of intravascular ultrasound imaging during endovascular interventions of failing hemodialysis access grafts." J Vasc Surg 65(5): 1383-1389.
Farber, M. A., W. A. Lee, W. Y. Szeto, J. M. Panneton and C. J. Kwolek (2017). "Initial and midterm results of the Bolton Relay Thoracic Aortic Endovascular Pivotal Trial." J Vasc Surg 65(6): 1556-1566 e1551.
Dana Bentley (Syntactx, New York City, NY) participated in the writing and technical editing of the manuscript.
Tassiopoulos, A. K., S. Monastiriotis, W. D. Jordan, B. E. Muhs, K. Ouriel and J. P. De Vries (2017). "Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors." J Vasc Surg 66(1): 45-52.
Schuurmann, R. C. L., K. van Noort, S. P. Overeem, K. Ouriel, W. D. Jordan, Jr., B. E. Muhs, Y. t Mannetje, M. Reijnen, B. Fioole, C. Unlu, P. Brummel and J. P. M. de Vries (2017). "Aortic Curvature Is a Predictor of Late Type Ia Endoleak and Migration After Endovascular Aneurysm Repair." J Endovasc Ther 24(3): 411-417.
Schuurmann, R. C. L., S. P. Overeem, K. Ouriel, C. H. Slump, W. D. Jordan, Jr., B. E. Muhs and J. P. M. de Vries (2017). "A Semiautomated Method for Measuring the 3-Dimensional Fabric to Renal Artery Distances to Determine Endograft Position After Endovascular Aneurysm Repair." J Endovasc Ther 24(5): 698-706.
van den Ham, L. H., A. Holden, J. Savlovskis, A. Witterbottom, K. Ouriel, M. Reijnen and E. T. I. E. S. Group (2017). "Editor's Choice - Occurrence and Classification of Proximal Type I Endoleaks After EndoVascular Aneurysm Sealing Using the Nellix Device." Eur J Vasc Endovasc Surg 54(6): 729-736.
Gagne, P. J., A. Gasparis, S. Black, P. Thorpe, M. Passman, S. Vedantham, W. Marston and M. Iafrati (2018). "Analysis of threshold stenosis by multiplanar venogram and intravascular ultrasound examination for predicting clinical improvement after iliofemoral vein stenting in the VIDIO trial." J Vasc Surg Venous Lymphat Disord 6(1): 48-56.
Dana Bentley (Syntactx, New York, New York) participated in the writing and technical editing of this manuscript.
Razavi, M., W. Marston, S. Black, D. Bentley and P. Neglen (2018). "The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction." J Vasc Surg Venous Lymphat Disord 6(2): 192-200.
Muhs, B. E., W. Jordan, K. Ouriel, S. Rajaee and J. P. de Vries (2018). "Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors." J Vasc Surg 67(6): 1699-1707.
Dana Bentley (Syntactx, New York, New York) provided medical writing services and prepared the initial draft of this manuscript.
Schuurmann RCL, van Noort K, Overeem SP, van Veen R, Ouriel K, Jordan WD, Jr., et al. Determination of Endograft Apposition, Position, and Expansion in the Aortic Neck Predicts Type Ia Endoleak and Migration After Endovascular Aneurysm Repair. J Endovasc Ther. 2018;25(3):366-75.
Briggs, C., T. Babrowski, C. Skelly and R. Milner (2018). "Anatomic and clinical characterization of the narrow distal aorta and implications after endovascular aneurysm repair." J Vasc Surg 68(4): 1030-1038.e1031.
Dana Bentley (Syntactx, New York, NY) assisted in the writing and technical editing of this manuscript.
Goudeketting SR, van Noort K, Ouriel K, Jordan WD, Jr., Panneton JM, Slump CH, et al. Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. Journal of vascular surgery. 2018;68(4):1007-16.
Shutze, W., V. Suominem, W. Jordan, P. Cao, S. Oweida and R. Milner (2018). "The incidence and effect of noncylindrical neck morphology on outcomes after endovascular aortic aneurysm repair in the Global Registry for Endovascular Aortic Treatment." J Vasc Surg (in press).
Dana Bentley (Syntactx, New York, NY) provided medical writing services for this manuscript.
Schneider, D. B., R. Milner, J. M. M. Heyligers, N. Chakfé and J. Matsumura. "Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings." J Vasc Surg (in press).
Dana Bentley (Syntactx, New York, NY) wrote the initial draft of this report and provided technical editing services.
Gagne, P.J., N. Gagne, T. Kucher, M. Thompson, T. Stewart, and D. Bentley. “Long-term clinical outcomes and technical factors with the Wallstent as treatment for chronic iliofemoral venous obstruction.” J Vasc Surg Venous Lymphat Disord (in press).
Black, S., A. Gwozdz, N. Karunanithy, J. Silickas, K. Breen, B. Hunt, A. Smith, A. Cohen and P. Saha "Two Year Outcome After Chronic Iliac Vein Occlusion Recanalisation Using the Vici Venous Stent." Eur J Vasc Endovasc Surg (in press).
Dana Bentley (Syntactx, New York, NY) wrote the initial draft of this manuscript, conducted statistical analyses, and provided medical writing services.
Lichtenberg, M., F. Breuckmann, W. F. Stahlhoff, P. Neglén and R. d. Graaf "Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions – short-term safety, patency, and clinical outcomes." Vasa (in press).
Jocelyn Marshall, PhD (Syntactx, New York, NY) provided medical writing services and prepared the initial draft of this manuscript; Dana Bentley provided supplemental services.
Kabnick, L. S., D. Recinella, M. Shifflette and K. Ouriel (2018). "Importance of Stent Shape and Area on Clinical Outcome After Iliofemoral Venous Stenting." J Vasc Surg Venous Lymphat Disord 6(2): 283-284.