NEMA SERVICES PHASE I-IV

Consulting Services:

Our goal at NEMA Research is to help you navigate the clinical trial process saving time, minimizing costs, and obtaining high quality data. Our dedicated team and globally recognized industry consultants work synergistically providing consulting services that will save you time and resources in a number of critical areas of the pre-clinical, clinical trial and regulatory processes. Some of the services include:

Protocol Design
Clinical Regulatory Support
- Support for IND/NDA/505(b2)
Statistical Support
Submissions Regulatory Support
Data Standards
Market Align Planning

Key Opinion Leader Registry:

The NEMA Research’s KOL Registry includes global thought leaders in their respective regulatory, clinical, and research fields. Members of the NEMA Research KOL Registry employ the depth and range of their experience and expertise to provide insight regarding your company’s product. They are ready to review and provide information at any stage of your product’s life cycle such as the regulatory process, clinical design, product manufacturing, product marketing and launch. The NEMA Members are ready to help you set company milestones and achieve your goals quickly and successfully.

Protocol Development:

Protocol development is a complex and timely process, critical for the undertaking of a clinical research study. The protocol is the framework to conducting a study, ultimately protecting the safety of trial subjects and the integrity and reproducibility of the data generated. Given the importance of the protocol, it should be developed by a team of clinicians with years of experience in the field.

NEMA Research’s team of well seasoned and experienced staff understands the importance of protocols. Our team collectively has participated in over 400 clinical studies including related studies on HIT, DIC, oncology, as well as acute/critical care, pain management, pharmacoeconomic and health outcomes. We can develop and design new protocols or modify existing ones, from the most simple to the most complex.

Medical Monitoring:

NEMA Research has access to several qualified physicians and nurses to serve as medical monitors/consultants for clinical trials. Their roles within a trial are governed by the complexity of the clinical trial as well as by our clients’ needs.

Some of the services provided by our medical monitors include:

Investigative Site Interactions

Overseeing enrollment by review of inclusion and exclusion questions generated by the site and providing critical feedback for inclusion waivers
Reviewing protocol deviations and providing corrective measures
Assisting investigative site personnel as needed in regards to protocol information or safety findings
Providing guidance with respect to treatment of any reactions as outlined in the protocol and other general guidance as needed
Interacting with the site and client to determine if any findings (Adverse Events or lab data) warrant further subject workup to better define and understand an event in relation to the study medication

Medical Consulting

Reviewing all Serious Adverse Events cases and narratives and providing regulatory recommendations and assessment of causality of each case
Addressing medical and safety questions from client personnel
Disseminating only scientifically sound information without regard to study outcomes and guiding the client as needed in these areas
Representing, as needed, the medical and safety personnel for any FDA meetings as requested by our clients

Project Management:

Since 1997, NEMA Research has assisted a variety of clients in successfully managing clinical research projects from initiation through completion and within their timelines and budget. Our Project Managers have experience in areas such as clinical monitoring, FDA guidance, and good clinical practices helping NEMA Research to communicate seamlessly with clients and ensuring that project objectives, work plans, and priorities are met within their deadlines.

NEMA Research believes that the key to conducting a successful clinical trial is a combination of:

Comprehensive project planning
Clear delineation of responsibilities
Personal accountability within the project team
Learning from past study experiences.

The NEMA Research Project Manager (PM) is responsible for the overall quality and performance of the entire project team and services provided to our clients. NEMA senior management will be available at all times to support the PM to ensure that timeline(s), milestones, and efficient delivery of quality deliverables are met. The NEMA PM maintains focused operations throughout the duration of the trial by placing an emphasis on open proactive communications, achievements, and solutions.

Clinical Monitoring:

NEMA Research’s CRAs bring vast clinical experience to each trial. They help manage study protocols while complying with regulatory guidelines, industry guidelines, and standard operating procedures. In addition, our CRAs work closely with the project's Data Management and Safety Board to ensure clinical data management and safety queries are addressed in a timely manner. Specifically, our Clinical Monitoring capabilities include:

Identification and selection of investigators
Identification and management of central institutional review boards
Regulatory document review and collection
Site contract, budget negotiation, and grant administration
Investigator meetings
On-site training
Site qualification, initiation, and closeout
Interim site monitoring
Drug accountability
Second clinical review
Data query resolution

Medical Writing:

NEMA Research’s medical writing staff draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements. The various backgrounds of our individual writers allow us to offer a wide range of regulatory and medical writing services to address the needs of every clinical research project including:

Investigator brochures
Protocol development
Informed Consent forms
Source documents and Case Report Forms
FDA briefing packages
Clinical study reports
Safety reports
Clinical monitoring reports
Market Aligned Development Plans
Interim data summaries
Abstracts and manuscripts
Conference posters
Data Dissemination planning services
Publication planning services

Decentralized Clinical Trials:

What are Decentralized Clinical Trials? The FDA defines decentralized clinical trials as operations where technology is used to communicate with study participants and collect data.

As health authorities worldwide struggle to contain the COVID-19 outbreak, there is a critical need to rapidly implement remote trial capabilities.

NEMA Research uses protocol-specific, tech-enable solutions to help with site selection, site activation, site recruitment, and site retention of subjects. This approach includes electronic consent, electronic diaries and assessments, and remote monitoring of site data. Our system improves the data quality and beneficial operational efficiencies throughout the clinical trial.

Regulatory:

NEMA Research provides a complete array of regulatory services during both the pre-clinical and clinical stages of product development. We have, or have access to, experienced personnel who have filed and maintained several IND/PMA/505(b)(2) applications across various therapeutic areas for both pharmaceutical and medical device products. We can also help facilitate communication between clients and regulatory authorities by aiding in various FDA meetings (ex. B and C type).

In addition, we can provide assistance or oversight for various clinical trial regulatory components including but not limited to:

Investigator Brochures
IRB submission process
Creation and maintenance of Trial Master File (TMF) and Investigator Site Files
Final audit, inventory and shipment of all documents to client

Data Management, Biostatistics and Technology:

The NEMA Research clinical data management team is composed of highly skilled clinicians who are experts in clinical design, biostatistics, and programming. As a team they offer a customized, cost-effective, and flexible approach to meet all of your data needs.

Some of our clinical data management services include:

Clinical Trial Power Analysis
Statistical Analysis Plan
CRF/eCRF design
Database development & deployment
Data entry and tracking
Customized clinical data management programming
Data conversion to any client's data specifications
Interim analysis readiness
Medical coding and serious adverse event (SAE) reconciliation
Database “lock” and delivery

Health Outcome Pharmacoeconomic Analysis:

The NEMA Research Team will perform a Health Outcome Pharmacoeconomic Analysis consisting of:

Literature reviews
Epidemiology profiling
Meta-analyses of competing clinical claims
Cost-effectiveness modeling
Budget impact analyses
Development and support for value propositions
Dossier preparation for formulary submissions in the U.S. and globally
Protocol assessment to meet formulary submission standards
Advise on clinical and patient reported outcomes in clinical trials
Advise on observational (including retrospective) study design

IRB Services:

NEMA Research’s Institutional Review Board (IRB) is composed of diverse individuals who collectively have over 50 years of clinical research experience. Many of these individuals have expertise in a variety of therapeutic specialties including medical devices, pharmaceuticals, nutraceuticals, and cosmeceuticals. In addition, our affiliate members, as well as our globally recognized consultants, are available to provide technical, scientific and therapeutic guidance when necessary.

Some of our IRB Services include:

Initial review of protocol, consent forms, case report forms, advertisement materials, sites and investigators
Post approval Services
Safety Monitoring
Continuing Review Services
HIPAA Waivers
Translations
Expedited Review Services

Feasibility:

At NEMA Research we understand the need to obtain high quality data. We accomplish this by selecting high quality, properly trained sites using our proprietary, pre-feasibility site testing process. This process begins with a well-designed online site questionnaire followed by an on-site meeting with the potential site‘s clinical and pharmacy teams. This leads to a mock performance of the study protocol testing for site-specific operational functionality and developing a site-specific clinical study materials implementation algorithm.

Our process familiarizes the site with the operational demands of the study, creates and tests the channel of communication between our team and the site study personnel, and identifies areas that need to be improved upon prior to the formal initiation of the trial. The pre-feasibility site testing process is proprietary to NEMA Research and is borne out of years of actual clinical research management.

Data Safety Monitoring:

A Data and Safety Monitoring Board (DSMB) — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. The DSMB assembled by NEMA Research is a group (typically 3 to 7 members) who are independent of the client sponsoring the trial. At least one DSMB member will be a statistician. Clinicians knowledgeable about the disease indication will be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. In addition, we can provide an ethicist or even a representative from a patient advocacy group. The DMSB normally convenes at predetermined intervals (three to six months typically) and review un-blinded results, i.e. results split by experimental and control arms. The DMSB has the power to recommend termination of the study based on the evaluation of these results.

Clinical Trial Rescue Services:

Sometimes clinical trials do not run efficiently or on-time and many times help is needed to put the trial back on track. The NEMA Research team is here to help. We have the ability to resolve trial issues by initially reviewing all trial elements including inclusion/exclusion criteria, trial objectives, site locations, investigators and study staff, and data management procedures and then implementing corrective actions (including initiating new study sites) if so required.