ExecuPharm’s Study and Site Start-Up suite of services can help clients maximize their site selection and initiation processes by reducing the likelihood of delays with more accurate timelines, enhanced tracking and document processing services that simplify the regulatory complexities of global trials. 

ExecuPharm recognizes that study start is the peak of a clinical trial’s activity that requires meticulous planning and development of key tools to facilitate a success. In addition to offering traditional-type site activation services.

ExecuPharm’s Study and Site Start-Up services can be customized to include a SWAT service that is streamlined to meet a variety of specific start-up support needs. 

ExecuPharm’s SWAT Start-Up services includes a team of subject matter experts trained on client’s SOPs, systems, applications, and have a wealth of best practice knowledge. They will partner with an organization to alleviate the need for long term additional resources, decrease learning curves and increase organizational efficiency. 

ExecuPharm’s SWAT Start-Up services include process improvement, infrastructural support that creates and fosters standardization and compliance across the organization, and an experienced pool of temporary resources that meet the peak period resourcing requirements.

 

ExecuPharm’s Study and Site Start-Up services to facilitate rapid trial starts include but are not limited to:

• Process Essential Documents

• Informed Consent Review

• Central IRB/EC Relationship Management

• Site Contract Management

• Electronic TMF Management

• Essential Document Approval for Activation

 

ExecuPharm’s SWAT services to facilitate rapid trial starts include but are not limited to:

• Provide assistance with document design and quality review of Study Monitoring Plan, Protocol Recruitment Plan, Vendor Oversight Plan, model Informed Consent Document and model recruitment materials and advertisements

• Assist with development of Protocol Feasibility Questionnaire, Site Assessment Questionnaire

• Review and advise with systems, study budgets and contracts

• Advise with preparation and planning of Investigator Meetings

• Assist with initial coordination of vendors and supply ordering

• Provide advisement and review for additional start-up activities 

 ExecuPharm  has the capability to administer clinical trial execution in a seamless cohesive manner as a stand-alone team (or assist in the administration) by augmenting resourcing to the established client team. ExecuPharm currently employs individuals with extensive pharmaceutical experience who specialize in clinical research and will be dedicated to your program from inception through completion. These individuals have a proven track record of executing over 2,200 global clinical studies since 2007. All individuals have been carefully screened and hand selected based upon their distinct educational and career knowledge of  the clinical research process. 

ExecuPharm’s Clinical Trial Administration and Management services include but are not limited to:

Site and Trial Monitoring Administration

Training

• Based on client structure and needs in accordance with job type and skill levels

• Utilizing a Train-the-Trainer method

• Combination of electronic (e.g., e-learning) and instructor-led

• Proactive monitoring and tracking of required training completion

Trial Administration

• eTMF set-up and maintenance

• eCTMS set-up and maintenance

• Equivalent online use of the client’s systems

ExecuPharm has the capability to perform monitoring and site management for clinical studies. ExecuPharm will complete all monitoring visits including Pre-Qualification, Site Initiation, Interim Monitoring and Close Out for all potential sites. ExecuPharm will work with the Sponsor to determine which data will be reviewed and collected at the visit according to the Monitoring Plan, as well as the requirements for monitoring visit report completion. Monitors can also be responsible to ensure the site has all the needed material to conduct the trial and can train and/or re-train any site staff as required.

ExecuPharm’s Monitoring and Site Management services include but are not limited to:

• Conduct feasibility assessment, site evaluation, site selection, initiation, routine monitoring and close-out visits

• Conduct site training 

• Collection of regulatory documentation 

• Manage and maintain site file and Trial Master File

• Manage ICF completion, including local country requirements and  translations

• Manage IRB submission/approval and reporting of safety information 

• Development and Negotiation of site budgets/contracts 

• Monitor/track site enrollment

• Management of Investigational product, study samples and study supplies 

• Source documentation verification/review of data collection per Monitoring Plan

• Facilitate of adverse event/serious adverse event reporting and follow-up 

• Contribute to audit responses

• Monitoring Visit Reports – timely documentation of findings and  follow-up 

ExecuPharm’s Clinical Trial Operations / Management Service has the capabilities to provide trial and program management expertise to coordinate and oversee all operational components of the entire clinical trial from inception to close-out. 

ExecuPharm can lead the program team, coordinate and track program activities, develop and enforce compliance with program timelines and budget, ensure adequate training and communicate progress and updates to key stakeholders. ExecuPharm has a proven track record, managing over 1,250 global clinical studies since 2006, built on experience, strong management capabilities and solid training that increase efficiency and quality. With the Sponsor’s agreement and input, our management team tracks and monitors key metrics and milestones to lay a foundation that measures their performance and continuous improvement. 

ExecuPharm’s Clinical Trial Management services include but are not limited to: 

• Protocol and Country Feasibility

• Site Selection

• Trial Start-up and Close Out 

       o Management of IRB/EC Submission

       o Site Contracts and Budgets

       o Essential Document Collection and Submission

• Patient Recruitment

• Patient Reported Outcome Measures

• Investigational Product Licensing 

• Data Management

• Implementation of Data Tools

• Process Training and Implementation

• Safety Risk Management including SUSAR and DSMB Support

• CRO Oversight

• Vendor Management

• Translation Management

• Quality Management

• Trial Master File Management

• Clinical Trial Registry Support

• Clinical Editing

• Medical Writing

ExecuPharm’s Clinical Trial Management teams serve as a Functional Service Provider (FSP) for several major clients:

• Team of Trial Managers/Senior Trial Managers for over 6 years

• Virtual or on-site Trial Managers based on client needs

• Experience profile for Trial Managers/Sr. Trial Managers:

       o 85% of Trial Managers with 11+ years pharmaceutical/biotech experience; 99% with 6+ years

       o 95% of Trial Managers with experience managing CROs

       o 98% of Trial Managers with experience running global studies; 73% with 6+ years

       o Extensive experience managing trial vendors (e.g. central labs, ECG, etc.)

       o Extensive experience working cross-functionally with other client disciplines

       o Majority of Trial Managers with experience  working within major client organizations  

ExecuPharm’s team of professionals becomes the Sponsor’s dedicated ‘hub’ of experts providing the highest level of oversight and proactively measuring vendor performance. ExecuPharm assesses risk at onset and prepares associated remediation plans should they be needed. Execupharm is adept at streamlining processes to increase efficiencies. Quality and adherence to timelines are critical to the development of your program and, having a qualified ExecuPharm Vendor Oversight Specialist in place will lead to significant cost saving measures.

This vendor oversight model helps lead the way to:

• Business continuity

• Productivity

• Decrease in cost

• Fewer project issues

• Adherence to  timelines

• Increased efficiency

• Rapid issue identification and resolution

• Open communication for all stakeholders

ExecuPharm’s innovative and flexible vendor oversight model allows a sponsor to focus on the core competencies of a program, while outsourcing one or several functional areas. These core processes and values take the everyday burden and challenges of clinical studies off the clinical team, management and all stakeholders leading to a faster, more cost efficient project.

ExecuPharm’s Vendor Oversight Services can help decrease the burden of the issues faced by pharmaceutical and biotech companies due to the required FDA mandates and ensures the project is conducted efficiently and expeditiously as possible to avoid issues in filing delays and/or time  to market.

ExecuPharm has the capabilities to conduct contract and grant negotiations contract management, and processing of payments between the Sponsor and the sites participating in a trial. ExecuPharm can be responsible for the entire process or work in conjunction with the Sponsor legal team to negotiate the agreement language and site trial budgets. 

ExecuPharm’s Contract and Grant Management service include but are not limited to:

• Reviewing and/or Negotiating and Managing Contracts for Research and Development and Scientific and Medical Affairs 

     o Consulting, Confidentiality and Clinical Trial Agreements

     o Informed Consents/HIPAA forms

     o Clinical Trial and Master Clinical Trial Agreements

     o Work Orders

     o Clinical Service and Consulting Agreements

     o Commercial Operations

     o Service Agreements with Consultants, Speakers, Vendors

     o Consulting and Confidentiality Agreements

     o Clinical Investigation Agreements

     o Informed Consents

     o HIPAA forms

     o Contract Research Organization Agreements

• Develop, Finalize, Negotiate and Maintain Trial Grants and Payments

• Developing and Implementing Tracking Logs

• Legal Departments Clinical Trial Process

• Finance Departments Clinical Trial Process

Data Management

ExecuPharm has the capability to supply Data Management services by creating a comprehensive Data Management Plan (DMP) to describe in detail all data handling procedures applied to the data throughout the trial from design through lock and archiving. This plan will be updated as necessary throughout a trial, with a revision history maintained.

ExecuPharm’s Data Management services include but are not limited to:

• Case Report Form and Database Design

• User Acceptance Testing

• Adverse Events/Medications/Medical History Coding

• Data Review/Cleaning

• Query Management

• Database Lock

• Archiving

 

Biostatistics

ExecuPharm has the capability to perform all the needed biostatistical activities related to a clinical trial. ExecuPharm can be responsible for the entire process or work in conjunction with the Sponsor for the overall analysis of clinical safety data in support of a regulatory submission. ExecuPharm has experience across a variety of compounds and indications in the conduct of integrated analyses specific to regulatory submissions. 

ExecuPharm’s Biostatistics services include but are not limited to:

• Statistical Analysis and Quality Review

• Collaborative Development of Statistical Analysis Plan

• Protocol and Case Report Form Design/Consultation

• Sample Size Determination and Randomization

• Analysis and Report Generation

• Produce Data Displays 

      o Patient Profiles

      o Tables, Figures, and Listings (TFLs)

• Interim and Final Analyses Reporting

 

Scientific and Medical Writing

ExecuPharm has the capability to supply both Regulatory Medical Writing and Educational Medical Writing services. Regulatory Medical Writing can include the creation of all regulatory documents required by regulatory agencies for drug, device and biologic approval process. Educational Medical Writing can include documents about drugs, devices and biologics for general audience in the pharmaceutical and health care industries. 

ExecuPharm’s Regulatory Medical Writing services include but are not limited to: 

• Clinical Trial Protocols

• Clinical Trial Reports

• Informed Consent Forms

• Investigator Brochures

• Summary Documents

• New Drug Applications 

     o Common Technical Documents

     o Clinical Overviews and Summaries

     o Integrated Analyses of Efficacy and Safety

• Manuscripts and Publications

• Annual Reports

• Drug Safety Update Reports

• Benefit-Risk Evaluation Reports

• Post-Approval Documentation

ExecuPharm’s Educational Medical Writing services include but are not limited to:

• Sales Literature

• Medical Conference Data Presentations

• Medical Journal Articles

• Continuing Medical Education

CMC Product Development

ExecuPharm’s CMC Product Development Services provides an unmatched model which maintains the flexible benefits of outsourcing with all the advantages of In-house operations. The Sponsor retains 100% control of activities and has immediate communication and direct oversight, thus maintaining project focus and assuring timelines are met. The complexities associated with out-sourcing are removed. All ExecuPharm resources are 100% dedicated to their assigned Sponsor. This eliminates the traditional lab CRO problem of competing for resources as well as the risk of loss of proprietary development and product knowledge.

ExecuPharm’s CMC Product Development services include but are not limited to: 

• Resourcing

      o 100% Fungible Resources Fully Aligned With Project Needs

      o Timely Identification and Placement of Key Talent with Sponsor Involvement as Desired

      o Individual and/or Team Hired as Full Time ExecuPharm Staff

          § Excellent Staff Retention

          § Co-Employment Avoidance

          § Quality

      o Fully Utilize Clients’ Quality Systems

         § LMS

         § SOPs

     o Eliminate Expensive Technical Transfer To External CROs

     o Eliminate Remote Auditing

• Integration

     o Fully Utilize Sponsor IT Systems

        § LIMS

        § Data Handling

     o No Transfer Of Data Required

     o Eliminate IT Compliance Issues

     o Client keeps technical expertise in house vs. outsourcing Client’s intellectual property

• Oversight

      o No Cost ExecuPharm Value Add Services

         § All Human Resource Activities 

         § Scientific, Compliance, Project and Management Consulting

         § Customized Governance 

 

Regulatory

ExecuPharm has the capability to assist clients with data reviews and gap analysis, as well as the development, implementation and management of strategic and operational regulatory plans at the country, territory or global level. ExecuPharm has worked with all the major regulatory agencies throughout North and South America, Europe, Africa, Australia and Asia. 

ExecuPharm is well-versed in country and regional customs, cultures, business practices as well as regulatory and ethical restrictions and considerations. 

ExecuPharm’s Regulatory services include but are not limited to: 

• Clinical Trial Applications

• New Drug Applications

• Biological Licensing Applications in the US

• Marketing Authorization Applications in Europe

• ICH Common Technical Document

 

Drug Safety

ExecuPharm has the capability to supply drug safety services including adverse event reporting. ExecuPharm will adhere to the Sponsor’s rules and regulations in determining and reporting whether the event is considered severe and take the immediate needed actions. 

ExecuPharm’s Drug Safety services include but are not limited to: 

• Drug Safety Project Management and Plan Development

• Collection and Follow-up of Serious Adverse Events (SAEs) from Clinical Studies

• Electronic Management of SAEs

• Expedited Reporting to Regulatory Authorities

• Expedited Reporting to IRBs, Ethics Committees and Investigator Sites

• Bi-annual and Quarterly Reporting to Regulatory Authorities, IRBs and Ethics Committees

• Eudravigilance Set Up and Management

• Responsible Person for Eudravigilance Oversight

• Reconciliation with Clinical Database

• Compliance Review and Oversight