Drug and Clinical Development Services

As a digital clinical research organization (dCRO), we focus on improving clinical development from the bottom up in order to save money and time. The result is a “lean” development program—a more efficient and affordable program that minimizes data integration, reduces project startup costs, and empowers stakeholders to make informed data-driven decisions.

Whether it is augmenting internal staff with a functional outsourcing approach or managing the program from beginning to end, we can do it, and do it more efficiently.

  • Analysis Data Model (ADaM)
  • Biostatistics
  • Clinical monitoring
  • Customized sourcing (FSP)
  • Data management
  • Global study feasibility
  • Medical affairs and writing
  • Patient recruitment
  • Pharmacovigilance and safety
  • Post-approval and registry
  • Project management
  • SAS
  • Site selection & management
  • Statistical programming
  • Regulatory & strategic consultancy
  • Regulatory submissions & filings
  • TEMPO™ eClinical Platform

Operationalize your clinical trial protocol
Whether you’re engaged in a single site, a 25-patient Phase I study, an adaptive Phase I/II trial, a large global Phase III trial with dozens of sites and thousands of patients, or a Phase IV safety study, we can help you affordably operationalize your clinical trial protocol and gain visibility into your clinical development program or individual project.

Real-time data access for better decision-making

Our TEMPO™ eClinical technology platform provides real-time access to the information you need for a more seamless decision-making clinical development process, including:

  • Site enrollment rates
  • Subject throughput rates
  • Data quality metrics
  • Study schedules
  • Real-time line listing reports
  • Medication dispensing
  • Milestone-driven payments
  • Adverse event and other data reports
  • Investigator payments

Biostatistics services
Our extensive Research Biostatistics Services (RBS) are tailored to meet your individual research needs, and can include:

  • Statistical support > study design, data safety monitoring boards (DSMBs), adaptive designs, manuscripts, and abstracts
  • Detailed statistical analysis plans, according to sponsor’s protocol and developed in collaboration with sponsor scientists
  • Randomization that ensures integrity of treatment masking
  • Real-time reporting
  • Planned and exploratory analyses documentation
  • Analysis of epidemiological endpoints, patient reported outcomes and econometric measures
  • Production of tables, listings and figures, audit-ready at delivery
  • Continuing scientific collaboration on ad hoc analyses, regulatory feedback, and annual safety reports
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results

Experience with power
Led by a world-class statistician with more than 30 years of clinical experience, all of our statisticians have advanced degrees and a deep understanding of:

  • Good Clinical Practices (GCP) as defined by the FDA and International Conference on Harmonisation (ICH)
  • Clinically-sound statistical methodologies
  • Clinical trial management and operations
  • Clinical Data Interchange Standard Consortium’s (CDISC), Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and Operational Data Model (ODM)
  • SAS software
  • 21 CFR Part 11

Quality services
Quality is the hallmark of any great team, and our biostatistical practice delivers GCP compliant analysis strategies, independent quality validation of formal deliverables to verify accuracy and audit readiness, as well as senior statistical review of all deliverables, from protocol writing through regulatory support.

Quality services
Quality is the hallmark of any great team, and our biostatistical practice delivers GCP compliant analysis strategies, independent quality validation of formal deliverables to verify accuracy and audit readiness, as well as senior statistical review of all deliverables, from protocol writing through regulatory support.

  • Ensuring signed informed consent forms
  • Completeness of data entry
  • Sourcing Data Verification (SDV), based on the protocol and monitoring plan
  • Reviewing all data and discussing trends with site staff
  • Evaluating source documentation and data for unreported serious adverse events
  • Performing drug accountability
  • Reviewing investigator study files for completeness
  • Ensuring protocol compliance
  • Encouraging and supporting sites

CRAs make final visits to sites to close out studies once all CRFs have been completed, reviewed, and locked in accordance with SOPs and study monitoring plan.

With TEMPO™, implementing and monitoring clinical trials and registries has never been more efficient and effective. TEMPO™’s online protocol and SOP training model enables our monitors to be up-and-running quickly. Whether guided by our SOPs or yours (sponsor), the efficient and expert use of TEMPO™ not only saves money, but also ensures study conduct occurs according to protocol while following GCP guidelines.

We employ top-notch CRAs who are led by experienced clinical operation managers and project managers. Clinipace monitors:

  • Must demonstrate site monitoring proficiency
  • Participate in ongoing training
  • Many have professional CRA certifications

Our CRAs are site managers
Unlike other CROs, our CRAs (”monitors”) serve as site managers. This ensures strong monitor-site relationships, helps maintain data quality and compliance, and expedites replies to monitoring requests. Trial teams can easily escalate site based study issues ensuring the entire project team is positioned to provide support and apply solutions as necessary while ensuring data quality. This streamlined approach efficiently provides information to the client hereby allowing for “real time” assessment and decision making to address the findings in a number of ways (i.e., client Good Clinical Practice (GCP) audits, client-PI interaction, etc.) maintaining data quality and having minimal impact to the project timeline.

Involved from study start through site closure, clinical operations managers and project managers provide oversight by:

  • Collaboratively working with sponsors and communicating every aspect of our monitoring activity throughout the engagement
  • Keeping projects on time or ahead of schedule
  • Mentoring CRAs and ensuring quality monitoring
  • Managing the clinical aspects of the study to ensure the collection of clean and quality data
  • Manage all site-related activities, visit schedules, and report preparation
  • Proactively identifying and resolving study-related issues

CRAs strive to maintain good working relationships with the staff and investigators at the trial sites. Rather than visiting only every couple months, or issuing queries and directives, a CRA can use remote data analysis findings as a basis to share feedback more informally. Additionally, the use of remote data analysis to detect small issues before they become big problems means the CRA can be less punitive and more collaborative. Frequent communication builds trust, fosters partnership and strengthens the relationship with the site. CRAs can work collaboratively with site personnel to proactively seek solutions rather than dictating what must be done.

Our focus is your data
As with all great research, good data is the difference between success and failure, and facilitating the efficient collection and management of clinical data is our only focus. Together with our award-winning TEMPO™ clinical research software platform, we offer Data Management Services (DMS) that ensure clean, accessible, quality data.

Built on TEMPO™, our data management services are designed to ensure:

  • Flexibility to meet your study needs
  • Complete visibility and management throughout the project lifecycle
  • Affordable, flexible electronic data capture (EDC) and study management software
  • EDC implementation best practices

“We turned to Clinipace Worldwide to serve as the glue to hold multiple clinical and regulatory projects together from a data management perspective. Having complete real-time visibility into study-level information is critical to our success.” 
– James O’Connor Vice President, Worldwide Regulatory, Quality, and Clinical Affairs, Surgeons Ethics and Compliance, Small Bones Innovations, Inc. (SBi)

In addition to the services included within every TEMPO™ deployment, we provide skilled staff that conducts:

  • Project management to ensure data quality and successful study completion
  • Case report form (CRF) development
  • Site audits for data integrity
  • Clinical/medical coding with industry standards (MedDRA, ICD, etc.)
  • Data validation and query resolution using TEMPO™
  • Data cleansing and quality assurance auditing
  • Complete management of electronic data capture (EDC) audit database
  • Project-specific data dictionaries
  • Reconciliation of external data
  • Data preparation for statistical analysis including derived variable creation and SAS programming

Data (quality) is the difference
Whether it is an interim report or data lock at study end, what matters is quality data. We assure data integrity by adhering to validated standard operating procedures (SOP) throughout any project. Our time-tested data quality processes include:

  • Adherence to good clinical practices (GCP) to ensure data consistency, quality, and integrity
  • Adaptive, single EDC and study management database
  • Data validation at the point-of-collection and automated data review
  • Flexibility to meet your study needs

Collaborative TEMPO™ eClinical deployment
We utilize a team approach with a dedicated project manager overseeing project plans, TEMPO™ implementations, staff deployment, and client interface. Our commitment to your project includes:

  • Project plan ensures complete visibility
  • Executive sponsor ensures accountability
  • Collaboration ensures quality
  • Training ensures adoption
  • Project team ensures lifetime support
  • Account management ensures access

“Clinipace’s technology and data management services allow us to provide our patients and families at the participating practice sites data-driven, evidence-based, and reliable care tailored to their individual disease status and needs.”
– Dr. Richard Colletti, Network Director of the ImproveCareNow Registry, Vice Chair of the Department of Pediatrics at the University of Vermont, and Associate Chief of Vermont Children’s Hospital

Good clinical practice training
Our good clinical practice (GCP) training curriculum includes International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards and regulations, and is customized for local authority regulations.

These custom in-person trainings are suitable for young and experienced clinical professionals involved in clinical trials worldwide. These services are both comprehensive and flexible, giving our clients the opportunity to learn and explore:

  • GCP introduction and framework
  • GCP guiding principles
  • Informed consent
  • Ethical treatment of patients
  • Investigator responsibilities
  • Sponsor responsibilities
  • Clinical trial protocol
  • Investigator brochure
  • Essential documents

Global study feasibility
Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity; alignment of the clinical trial in terms of study design, dose of investigational product, comparator, and patient type with the local environment, and assessing potential of conducting clinical trial in a specific country.

A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical and medical device firms, this is a precursor to study placement and influences the decision of study placement. Our analysis saves time and money and includes the following assessments:

Site identification and qualification
We utilize several approaches in identifying qualified sites and investigators. We consider the site’s location, staffing, qualifications, history, clinical trial experience, area of therapeutic experience, GCP/ICH compliance, and patient population/enrollment history. We collaborate with you to select sites that will successfully meet your project needs.
Our analysis tools will assist us in accurately determining which regions and sites will produce the best performance and probability of success.

Patient population/target group
Our trial operations experts analyze available patient demographic data and work with patient advocacy organizations and physicians to understand how, when, and where patients and their support groups can be reached. By identifying the correct patient population and by focusing on the right target group, you save both time and money during the recruitment period.

Competing trials
Successful patient recruitment also depends on the number of competing trials in the region of your trial, as well as the number of trials being performed at your investigator sites. We conduct both primary and secondary analysis of competing trial data in relation to your clinical study and provide you with accurate reports.

Patient accrual
Our integrated approach to subject recruitment promotes subject trust and understanding by delivering recruitment messages in multiple ways with the appropriate frequency and consistency.

Through an ongoing client communication and technology-based approach, Clinipace Worldwide can identify trends and respond in near real-time to fluctuations in media inventory, media saturation, and site enrollment performance. Working together with our clients, we develop a media plan and creative content that best meets the project enrollment goals.

Our creative team will work with you to understand your study objectives and create messaging strategies and programs that include broadcast and print advertising, online campaigns, printed/digital study material, direct response mailings, and public relations.

The rate at which new patients are accrued can make or break a clinical trial’s timeline and budget. When sites are slow to enroll patients, timelines are delayed and related costs go up.

However, slow accrual can be mitigated with real-time visibility into site performance. Through our technology-amplified approach, we bring real-time clarity to potential enrollment problems so they can be addressed much more quickly. At-your-fingertips information allows us to identify trends and deploy resources more appropriately based on fluctuations in media inventory, media saturation, and site enrollment performance.

“It used to be that when I asked how many patients had been enrolled in one of our trials, I got five different answers depending on the department to which I directed the question.  What’s more, it took anywhere from 30 minutes to 24 hours to get those five answers.  Now, the answers to these questions are immediately available at my fingertips.”
– Study sponsor

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