Clinical Research Business Development
Resume:
ROBERT JAMES SOARES, BSc., CCRP
Clinical Research Professional
Tampa, FL, US ****************@******.*** 813-***-**** PROFESSIONAL SUMMARY
Experienced Clinical Research Professional with over 16 years of experience in clinical research and 6 years as a Clinical Research Monitor. Adept at managing Phase I–IV studies, site monitoring, informed consent procedures, and regulatory compliance. Certified Clinical Research Professional (CCRP) with deep expertise in ICH-GCP and FDA-CFR guidelines. Skilled in risk-based monitoring, SOP review, CAPA development, and feasibility analysis. Recognized for building collaborative site relationships and executing high-quality research programs. Experienced in Site Feasibility & Business Development. CORE SKILLS
• Clinical Trial Monitoring & Completion of Monitoring Reports (SIV, PAV, Remote/Onsite IMVs, Close-out)
• Phase I–IV Studies Risk-Based Monitoring- Centralized and Decentralized Trials
• ICH-GCP & FDA-CFR Compliance
• Site, CRO, and Sponsor SOP & CAPA Development and Review
• Source, Regulatory, CRF, TMF, & EDC- Documentation, Completeness, and Review
• Informed Consent Review & Collection
• Drug Accountability & Storage
• Stakeholder Communication & Problem Solving
• Site Business Development, Feasibility, Recruitment & Client Management
• Site Audit Readiness & Audit Preparation
• Systems: Oracle, IMPACT 14, Realtime CTMS, Veeva Vault, Medidata Rave, Inform, Salesforce, Florence, Versa-Trial, Bracket, & Study Optimizer
CERTIFICATION
Certified Clinical Research Professional (CCRP) – SoCRA (Valid through April 2028) PROFESSIONAL EXPERIENCE
TrueBlue Clinical Research (formerly Moore Clinical Research) – Tampa, FL/ Hybrid Client and Feasibility Manager Nov 2023 – Nov 2024
• Letter of Recommendation from President and Executive Director
• Plan, develop, and oversee the overall client relationship strategy for the company; clients include Sponsors, CROs, Medical Science Liaisons, and community physicians
• Collaborate with the Executive Director and other managers to plan for, and execute, the financial success of the company
• Identify new markets and trial opportunities; provide leads to the executive team
• Identifies, initiates communications and establishes formal relationships with community businesses and physicians for developing relationships and trial subject recruitment initiatives; supports the ongoing relationship with these community partners
• Manage the daily operation of the Recruitment Team; time and attendance, performance metrics, and general management support
• Plan, organize and executive Recruitment initiatives and strategies as they relate to specific studies, trial indications and/or therapeutic areas 2
• Develop existing Sponsor/CRO and other key stakeholder relationships to ensure optimal standing
• Utilizes and is proficient in, platforms, software and systems used by the company for tracking, submitting, and reporting trial leads and opportunities
• Maintain organized and accurate company records for feasibility questionnaires, study synopses, confidentiality agreements, study pipeline, study portfolio, and proposed study budgets
• Understand the company’s market rate for completing exams, procedures; able to develop and negotiate study budgets that maximize the company’s revenue potential
• Contact potential clients to establish a rapport, build strong relationships, discuss site capabilities, and sell the research strengths of the company; research and seek out new study opportunities through established avenues, as well as seek out new leads of business opportunity through new Sponsors and CROs
• Conduct regular market research in the clinical research industry to identify trends in research and explore potential new indications, specialties for the company
• Attend industry conferences, educational symposiums and other venues in which company promotion is achieved
• Problem-solve barriers to bringing new studies to the pipeline (e.g., new investigators, lab or imaging procedures that need outsourcing)
• Maintain positive rapport with all current Sponsor, CRO, and vendor contacts and relationships, routinely follow up on potential study leads and/or cold calling to determine potential study leads
• Establish and maintain effective working relationships with vendors, employees, and other company leaders. Supports a positive image inside and outside the organization
• Develops strong inter-department teamwork to meet the needs and goals of the company and drive decision making processes and other actions
• Collaborate with the other managers to plan, coordinate and organize events that generate name recognition, support recruitment efforts, and provide community outreach
• Supports and conducts behaviors commensurate TBCR Employee Standards; trains and coaches subordinates as deemed necessary
• Remote/hybrid work schedule
Parexel / Worldwide Clinical Trials – Tampa, FL / Remote Clinical Operations Manager/ Sr. CRA Jun 2022 – Mar 2023 Clinical Operations Manager/ Sr. CRA Apr 2022 – May 2022
• Perform site selection (PAV), initiation (SIV), monitoring (RMV/IMV), and close-out visits in accordance with contracted scope of work and good clinical practice.
• Verify the investigational sites assigned to are conducting the study in accordance with ICH-GCP and FDA-CFR requirements
• Regularly review site delegation log to verify only qualified and trained personnel are completing tasks they are delegated to perform and meet qualifications to perform them per local/national laws and licensing requirements.
• Ensure all staff members on study have been trained and documentation of the training has been made appropriately within site regulatory records.
• Support development of project subject recruitment plan on a per-site basis.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
3
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
o 3-5 Protocols assigned at a time; Between 8-14 sites assigned at a time.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Monitor sites for protocol deviations including ensuring site documentation is made, reported to IRB/IEC per guidelines, and addressing root-cause analysis with CAPA as needed.
• Confirm all enrolled trial subjects meet inclusion/exclusion criteria per protocol.
• Ensure subjects ongoing protection of rights, safety and well-being throughout the study including documentation made to confirm subjects’ willingness to continue participating in trial.
• Review site documentation and reasons for any early withdrawals including confirmation of reason is provided both in source and CRF/EDC system
• Conduct and assist sponsor audits of clinical research sites reviewing informed consent is properly obtained and documented, IRB/IEC approvals and obligations for consenting have been met. Verifying all AEs/ SAEs/ and AESIs are documented with causality determined by qualified and delegated individuals, reported to sponsor, and IRB/IEC within the appropriate timelines per regulatory requirements, study protocol, and sponsor SOPs.
• Confirm investigator receipt, acknowledgement, and dissemination of information is documented related to any IND safety reports and SUSARs to appropriate staff.
• Review concomitant medications, procedures, lab reports to ensure documentation, reporting, and compliance with study protocol and safety requirements including no prohibited medications are not administered.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Prepare, complete, and submit detailed monitoring visit reports, including any findings, noncompliance issues, and recommended corrective and preventative actions (CAPA)
• Provide sites with a follow-up letter outlining item(s) captured during each visit including all items detailed within monitoring report.
• Escalate quality issues as appropriate.
• Perform source data verification and source data review as outlined within protocol specific trial monitoring plan to ensure all data in case report forms match source documents.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution within appropriate timelines per protocol and sponsor SOPs.
• Support start-up phase.
• Collect, submit, and ensure completeness of Trial Master File across sponsor, vendors, and sites.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Confirm only authorized personnel have access to and dispense the investigational product, IP accountability logs are complete and accurate at both the subject and the site level. Storage conditions are appropriate, and temperature logs confirm compliance for storage conditions. Verify dispensed medication aligns with accountability logs and any used, expired, or unused IP is destroyed (protocol requirements met) or returned to sponsor at end of study.
• Collaborate and liaise with study team members for project execution support as appropriate.
• Management tasks of role include mentoring, training, and providing assistance to onboarding monitors and tracing compliance of training. 4
DOCS Global (ICON PLC) – Tampa, FL / Remote (Up to 70% Travel) Clinical Research Associate II Jul 2020 – Feb 2022
• Perform site selection (PAV), initiation (SIV), monitoring (RMV/IMV), and close-out visits in accordance with contracted scope of work and good clinical practice.
• Verify the investigational sites assigned to are conducting the study in accordance with ICH-GCP and FDA-CFR requirements
• Regularly review site delegation log to verify only qualified and trained personnel are completing tasks they are delegated to perform and meet qualifications to perform them per local/national laws and licensing requirements.
• Ensure all staff members on study have been trained and documentation of the training has been made appropriately within site regulatory records.
• Support development of project subject recruitment plan on a per-site basis.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
o 3-5 Protocols assigned at a time; Between 8-16 sites assigned at a time.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Monitor sites for protocol deviations including ensuring site documentation is made, reported to IRB/IEC per guidelines, and addressing root-cause analysis with CAPA as needed.
• Confirm all enrolled trial subjects meet inclusion/exclusion criteria per protocol.
• Ensure subjects ongoing protection of rights, safety and well-being throughout the study including documentation made to confirm subjects’ willingness to continue participating in trial.
• Review site documentation and reasons for any early withdrawals including confirmation of reason is provided both in source and CRF/EDC system
• Conduct and assist sponsor audits of clinical research sites reviewing informed consent is properly obtained and documented, IRB/IEC approvals and obligations for consenting have been met. Verifying all AEs/ SAEs/ and AESIs are documented with causality determined by qualified and delegated individuals, reported to sponsor, and IRB/IEC within the appropriate timelines per regulatory requirements, study protocol, and sponsor SOPs.
• Confirm investigator receipt, acknowledgement, and dissemination of information is documented related to any IND safety reports and SUSARs to appropriate staff.
• Review concomitant medications, procedures, lab reports to ensure documentation, reporting, and compliance with study protocol and safety requirements including no prohibited medications are not administered.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Prepare, complete, and submit detailed monitoring visit reports, including any findings, noncompliance issues, and recommended corrective and preventative actions (CAPA)
• Provide sites with a follow-up letter outlining item(s) captured during each visit including all items detailed within monitoring report.
• Escalate quality issues as appropriate.
• Perform source data verification and source data review as outlined within protocol specific trial monitoring plan to ensure all data in case report forms match source documents.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution within appropriate timelines per protocol and sponsor SOPs.
• Support start-up phase.
• Collect, submit, and ensure completeness of Trial Master File across sponsor, vendors, and sites.
5
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Confirm only authorized personnel have access to and dispense the investigational product, IP accountability logs are complete and accurate at both the subject and the site level. Storage conditions are appropriate, and temperature logs confirm compliance for storage conditions. Verify dispensed medication aligns with accountability logs and any used, expired, or unused IP is destroyed (protocol requirements met) or returned to sponsor at end of study.
• Collaborate and liaise with study team members for project execution support as appropriate.
• Travel up to 70%
IQVIA – Tampa, FL / Remote (55-70% Travel)
Sr. Clinical Research Associate I Jul 2018 – Jun 2020 Clinical Research Associate II Mar 2016 – Jun 2018
• Received "Above and Beyond Expectations" Award (2018) for performance excellence.
• Perform site selection (PAV), initiation (SIV), monitoring (RMV/IMV), and close-out visits in accordance with contracted scope of work and good clinical practice.
• Verify the investigational sites assigned to are conducting the study in accordance with ICH-GCP and FDA-CFR requirements
• Regularly review site delegation log to verify only qualified and trained personnel are completing tasks they are delegated to perform and meet qualifications to perform them per local/national laws and licensing requirements.
• Ensure all staff members on study have been trained and documentation of the training has been made appropriately within site regulatory records.
• Support development of project subject recruitment plan on a per-site basis.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
o 3-5 Protocols assigned at a time; Between 10-18 sites assigned at a time.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Monitor sites for protocol deviations including ensuring site documentation is made, reported to IRB/IEC per guidelines, and addressing root-cause analysis with CAPA as needed.
• Confirm all enrolled trial subjects meet inclusion/exclusion criteria per protocol.
• Ensure subjects ongoing protection of rights, safety and well-being throughout the study including documentation made to confirm subjects’ willingness to continue participating in trial.
• Review site documentation and reasons for any early withdrawals including confirmation of reason is provided both in source and CRF/EDC system
• Conduct and assist sponsor audits of clinical research sites reviewing informed consent is properly obtained and documented, IRB/IEC approvals and obligations for consenting have been met. Verifying all AEs/ SAEs/ and AESIs are documented with causality determined by qualified and delegated individuals, reported to sponsor, and IRB/IEC within the appropriate timelines per regulatory requirements, study protocol, and sponsor SOPs.
• Confirm investigator receipt, acknowledgement, and dissemination of information is documented related to any IND safety reports and SUSARs to appropriate staff.
• Review concomitant medications, procedures, lab reports to ensure documentation, reporting, and compliance with study protocol and safety requirements including no prohibited medications are not administered.
6
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Prepare, complete, and submit detailed monitoring visit reports, including any findings, noncompliance issues, and recommended corrective and preventative actions (CAPA)
• Provide sites with a follow-up letter outlining item(s) captured during each visit including all items detailed within monitoring report.
• Escalate quality issues as appropriate.
• Perform source data verification and source data review as outlined within protocol specific trial monitoring plan to ensure all data in case report forms match source documents.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution within appropriate timelines per protocol and sponsor SOPs.
• Support start-up phase.
• Collect, submit, and ensure completeness of Trial Master File across sponsor, vendors, and sites.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Confirm only authorized personnel have access to and dispense the investigational product, IP accountability logs are complete and accurate at both the subject and the site level. Storage conditions are appropriate, and temperature logs confirm compliance for storage conditions. Verify dispensed medication aligns with accountability logs and any used, expired, or unused IP is destroyed (protocol requirements met) or returned to sponsor at end of study.
• Collaborate and liaise with study team members for project execution support as appropriate.
• Travel up to 55%
USF Health, Neurology, Multiple Sclerosis Division – Tampa, FL / On-Site Clinical Research Coordinator Jun 2014 – Mar 2016 Research Assistant Mar 2009 – May 2014
• Assist during monitoring visits to follow-up on audit findings and provide resolution.
• Keep an up-to-date record of regulatory documents including delegation and training logs, FDA-1572, and IRB/IEC records.
• Reference and adhere to site recruitment plan including updating IRB/IEC and sponsor gaining sponsor approval for changes to enrollment cap.
• Provided lead coordinator oversight on up to 11 protocols at a time and backup coordinator oversight on up to 12 trials at a time.
• Keep in regular line of communication with study monitors and sponsor for any protocol related changes, amendments, or reporting items for safety/drug storage excursions.
• Ensure documentation is made to to all protocol deviations, reported to IRB/IEC per guidelines, and address root-cause analysis with CAPA as needed.
• Confirm all enrolled trial subjects meet inclusion/exclusion criteria per protocol.
• Ensure subjects ongoing protection of rights, safety and well-being throughout the study including documentation made to confirm subjects’ willingness to continue participating in trial.
• Document all subject withdrawals and reasons for any early withdrawals including confirmation of reason is provided both in source and CRF/EDC system
• Report all AEs/ SAEs/ and AESIs to IRB/IEC, monitor, and complete all related follow- up or updates. Ensure causality is determined by qualified and delegated individuals, 7
reported to sponsor, and IRB/IEC within the appropriate timelines per regulatory requirements, study protocol, and sponsor SOPs.
• Review concomitant medications, procedures, and lab reports to ensure documentation, reporting, and compliance with study protocol and safety requirements are made and no prohibited medications are administered.
• Follow-up on any open action items addressed within all monitoring visit follow-up letters.
• Escalate quality issues as appropriate including temperature excursions and handle appropriate actions for quarantine of study drug as needed.
• After visits complete any CRF/EDC submissions for visit data, safety and CMED updates to sponsor.
• Develop initial source documents at initiation of study and any changes needed during protocol amendments
• Provide assistance with design of study tools, documents and processes.
• Keep up to date IP accountability logs for both the subject and site. Keep ongoing record of temperature logs and report any excursions. Verify dispensed medication aligns with accountability logs and any used, expired, or unused IP is destroyed (protocol requirements met) or returned to sponsor at end of study.
• Collaborate and liaise with study team members for project execution support as appropriate.
THERAPEUTIC AREA EXPERIENCE
• CNS – 14 Years- Multiple Sclerosis, Alzheimer’s, Parkinson’s & CIDP trials
• Ophthalmology– 2 Years- Diabetic Macular Edema & Age-Related Macular Degeneration trials
• Oncology- 1 Year- Multiple Myeloma trial
• Dermatology– 1 Year- Hidradenitis Suppurativa, Atopic Dermatitis, Alopecia, Acne & Vitiligo trials EDUCATION
The University of Tampa – Tampa, FL- May 2014
Bachelor of Science (BSc.), Biochemistry Minor: Criminology PUBLICATIONS & RESEARCH PRESENTATIONS
• Optimization of Chemical Inhibition Conditions for NMD Studies in p53+ Cancer Cell Lines – Experimental Biology Conference, 2014
• Eosinophil Elevation with Dimethyl Fumarate Use in MS – CMSC Annual Meeting, 2014 AWARDS & ENDORSEMENTS
• Letter of Recommendation from President and Executive Director- TrueBlue Clinical Research Nov 25, 2024
• Above and Beyond Expectations Award – IQVIA / Roche Oct 31, 2018 Recognized for exemplary performance and professional excellence. 8
Comprehensive Clinical Research Project History List Below
(Chronologically Ordered Below)
Sanofi
A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab
Extension Study (CAMMS03409) CRA II: Oct 2021-
February 2022
Sanofi
A Phase 3 Randomized, Open Label, Multicenter
Study of Isatuximab (SAR650984) in Combination
With Lenalidomide and Dexamethasone Versus
Lenalidomide and Dexamethasone in Patients With
High-risk Smoldering Multiple Myeloma CRA II: July 2021- February 2022
Sanofi
A Validation Study to Assess the Validity,
Measurement Responsiveness, & Reliability of the
Parkinson’s Disease Functional Impacts Digital
Instrument (PD-FIDI)
CRA II: May2021- February 2022
Sanofi
A Phase 2, multicenter, open-label, non-
randomized, proof-of-concept study evaluating the
eYicacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating
polyneuropathy (CIDP) CRA II: Mar 2021- August
2021
Sanofi
A Phase 3, randomized, double-blind, eYicacy and
safety study comparing SAR442168 to placebo in
participants with primary progressive multiple
sclerosis (PERSEUS) CRA II: September 2020- April
2021
Sanofi
A Phase 3, randomized, double-blind eYicacy and
safety study comparing SAR442168
to teriflunomide (Aubagio®) in participants with
relapsing forms of multiple sclerosis (GEMINI 2)
CRA II: August 2020- April 2021
Sanofi
A Phase 3, randomized, double-blind eYicacy and
safety study comparing SAR442168
to teriflunomide (Aubagio®) in participants with
relapsing forms of multiple sclerosis (GEMINI 1)
CRA II: August 2020- April 2021
Sanofi
A Phase 3, randomized, double-blind, eYicacy and
safety study comparing SAR442168 to placebo in
participants with nonrelapsing secondary
progressive multiple sclerosis (HERCULES) CRA II:
August 2020- April 2021
F. Ho/mann-La Roche, Ltd.
A Phase Ib, Open-Label, Multicenter, Study to
Investigate the Pharmacokinetics, Safety, and
Tolerability of Subcutaneous Ocrelizumab
Administration in Patients with Multiple Sclerosis Sr.CRA1: April 2019- June 2020
F. Ho/mann-La Roche, Ltd.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, EYicacy, and
Safety Study of Gantenerumab in Patients with
Early (Prodromal to Mild) Alzheimer’s Disease Sr.
CRA1: Sep 2017- June 2020
F. Ho/mann-La Roche, Ltd.
A Phase IIIb, Multicenter, Randomized, Parallel-
Group, Open-Label Study to Evaluate the EYects of
Ocrelizumab on Immune Responses in Patients
with Relapsing Forms of Multiple Sclerosis Study
Coordinator: June 2015- March 2016; CRA2: May
2018- June 2018; Sr.CRA1: July 2018- June 2020
F. Ho/mann-La Roche, Ltd.
A Phase III, Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group, Multicenter, EYicacy
and Safety Study of Gantenerumab in Patients with
Mild Alzheimer’s Disease; Part II: Open-Label
Extension for Participating Patients CRA2: May
2016- June 2018; Sr. CRA1: July 2018- Nov 2018
F. Ho/mann-La Roche, Ltd.
A Multiple-Center, Multiple-Dose and Regimen,
Randomized, Active Comparator
Controlled, Double-Masked, Parallel Group, 36
Week Study to Investigate the Safety,
Tolerability, Pharmacokinetics, and EYicacy of
RO6867461 Administered Intravitreally in Patients
9
with Choroidal NeoVascularization Secondary to
Age-Related Macular Degeneration CRA2: May
2016- Dec 2017
F. Ho/mann-La Roche, Ltd.
A Multiple- Center, Multiple- Dose, Randomized,
Active Comparator-Controlled, Double Masked,
Parallel-Group, 36-Week Study to Investigate the
Safety, Tolerability, Pharmacokinetics, and EYicacy of RO6867461 Administered Intravitreally in
Patients with Diabetic Macular Edema CRA2: May
2016- Dec 2017
F. Ho/mann-La Roche, Ltd.
Multicenter, Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group Two Year Study
to Evaluate the EYect of Subcutaneous RO4909832
on Cognition and Function in
Prodromal Alzheimer’s Disease with Option for up
to an Additional Two Years of Treatment and up
to Three Years of an Open-Label Extension with
Active Study Treatment CRA2: May 2016- Aug 2016
Biogen
A Multicenter, open label phase IV study to evaluate whether a Medication Event Monitoring System
(MEMS) can improve adherence to Tecfidera
(delayed- release dimethyl fumarate) treatment in
multiple sclerosis patients Study Coordinator: June 2015 - March 2016
Biogen
A Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study of the EYicacy and Safety of
BG00012 in Delaying Disability Progression in
Subjects With Secondary Progressive Multiple
Sclerosis Study Coordinator: April 2015 - March 2016 Actelion
OPTIMUM: Oral Ponesimod versus Teriflunomide in
relapsing Multiple sclerosis Multicenter,
randomized, double-blind, parallel-group, active-
controlled, superiority study to compare the
eYicacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis Research Assistant: April 2015 - March 2016
Biogen, Idec.
A Multicenter, Randomized, Double Blind, Placebo
Controlled Study to Assess the Long-Term EYicacy
and Safety of Prolonged Release Fampridine
(BIIB041) 10 mg, Administered Twice Daily in
Subjects with Multiple Sclerosis (ENHANCE) Study
Coordinator: November 2014 - March 2016 Sponsor-
Investigator Initiated, University of South Florida, Derrick Robertson, MD Rapid Elimination Procedure
of Teriflunomide with Colestipol Hydrochloride
Study Coordinator: October 2014 - March 2016
Biogen, Idec.
A multicenter, global, observational study to collect information on safety and to document the drug
utilization of TecfideraTM(dimethyl fumarate) when
used in routine medical practice for the treatment of multiple sclerosis Study Coordinator: May 2014 - March 2016
Biogen, Idec.
A Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study of the EYicacy of Natilizumab on
Reducing Disability Progression in Subjects with
Secondary Progressive Multiple Sclerosis, With
Optional Open-Label Extension Study Coordinator:
May 2014 - March 2016
Novartis
A multicenter, randomized, double-blind, parallel- group, placebo-controlled variable treatment
duration study evaluating the eYicacy and safety of Siponimod (BAF312) in patients with secondary
progressive multiple
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