- North America
- United States
- Human Medicines, Biopharmaceuticals
- Service category
- Clinical development and testing, clinical CRO
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- Clinical monitoring
- Clinical trial services
- Electronic data management
- Patient recruitement services
- Project management
- Regulatory services
- Statistical service / biostatistics / biometrics
- Writing medical
Clinical Trial Management
STAR (Site Tracking and Recruitment)
STAR technology provides added value and efficiency. ACORN CRO’s experienced project managers guided development of STAR to save valuable time during the study start-up phase. The resulting system delivers solutions that provide meaningful cost benefits to both sponsors and participating sites. STAR substantially accelerates the study start-up process which results in impressive economies of scale.
- ACORN CRO proprietary technology dedicated to speeding site selection
- Automates the study feasibility process
- Increases transparency and efficiency in the site feasibility/selection process
- Allows complete tracking of the status of each site contacted
- Sponsors may view status at any time
- Generates site feasibility metrics in real time
- Seamlessly sends reminder notifications
- Reduces the need for sites to complete repetitive tasks
- Saves approximately 75% of the time traditionally spent on study feasibility forms. Streamlines and makes communication easier as it frees sites and ACORN from unnecessary paperwork.
- Site Repository enables rapid selection of potential study sites based upon sponsor requirements.
- Responsive, accessible, flexible
- Have met or exceeded enrollment of 1st patient prior to the FPFV target date
- Database with over 600 oncology research sites for rapid and accurate site identification, utilizing STAR tool
- Experienced project managers – average of over 39 oncology studies per PM
- Proprietary technology streamlines processes
The ACORN CRO Project Management process ensures that quality is implemented in every step of the trial process. Our thorough knowledge of oncology eliminates any potential delay in getting up to speed on a trial. We know our specialty well, and we are ready.
Our experienced Project Managers implement trials as quickly as possible. Comprehensive project plans as well as clear, on-going communication channels help expedite every phase of a study from sponsor to site to all points in between, including project vendors. We appreciate what is at stake for our sponsors, and we operate with exceptional timelines to achieve sponsor goals. We spend the time it takes to facilitate the successful implementation and operation of a trial. Daily oversight and proactive trouble-shooting are byproducts of our commitment to excellence.
The Monitoring Services Department is comprised of experienced, credentialed professionals who ensure clinical trials are conducted in accordance with the protocol, standard operating procedures, Good Clinical Practices and applicable FDA guidelines. ACORN CRO monitors also use their expertise to ensure that internal and external customer requests are completed with the appropriate resources and within acceptable guidelines.
ACORN CRO CRAs focus to ensure patient safety and data integrity by conducting:
- Site evaluation, initiation, routine monitoring and close-out visits
- Thorough review of the informed consent process, IRB approvals, AE/SAE reporting, and follow-up along with source verification of all subject data
- Investigational product accountability review
- Site training and site support
- Essential document management, trip report tracking, and co-monitoring visits
- Rapid query resolution
While conducting on-site monitoring visits, the monitors strive to develop a professional working relationship with the site staff and prove to be a great asset in their role as the primary line of contact between the Investigative staff and the CRO. Years of oncology experience aid the monitors in query resolution as well as reviewing Adverse Event reporting. Our monitors understand the constraints facing today’s oncology practices and as a result, their professional demeanor is as welcome as the sensitivity and expertise they bring to each research site.
ACORN CRAs receive monthly training to remain current with industry trends and changing regulations.
With its wealth and depth of oncology experience, ACORN CRO can provide meaningful insight regarding protocol design. As leaders in the field of oncology, we have immediate access to key oncology opinion leaders throughout the country whose insight and experience can play pivotal roles in the development of sponsor protocols. We know how to avoid obstacles that could impede a trial’s acceptance by investigators. We will help you develop a protocol that provides the information you need for final approvals while making it attractive to prospective investigators.
Regulatory Document Management
The regulatory team at ACORN CRO recognizes how vital a prompt start-up is to trial initiation. Intuitive, straightforward trial start-up packages and support make an important difference in how quickly sites complete regulatory requirements. Add to that our knowledgeable, committed regulatory staff, and successful results become immediately apparent to both sponsors and participating investigators.
Rely on ACORN CRO Regulatory for:
- Comprehensive trial start-up packages (containing all essential study documents, forms and templates as appropriate)
- Immediate consultation as needed
- Dedicated associate for each study
- Management of initial and updated study document submissions to the Central IRB and participating sites (protocol, consent form, investigator’s brochure, IND safety reports, patient materials, etc.)
- IND exemption requests and IND submissions to the FDA
- Status tracking throughout submission process
- Timeline tracking for IRB reapprovals to avoid lapses in IRB approval
- Collection, oversight and maintenance of regulatory documents for sponsor records
At ACORN CRO, we recognize the importance that efficient patient accruals play in your project. We begin with sites committed to the research process. ACORN CRO then provides the means for successful patient recruitment via
- Strong, engaged and highly experienced Project Managers
- Comprehensive investigator and staff training
- On-going communications, including trial newsletters
- Availability of targeted patient recruitment marketing materials (ranging from websites, in-clinic information to paid advertisements)
Our medical review team consists of board certified oncologists/hematologists who are leaders in their respective specialty. As is expected, primary focus is on safety issues that occur during the course of the trial. Equally important is our treatment trend analysis that could affect the overall progress of the respective trial. Rather than working in isolated corporate environs, our medical monitoring teams always include physicians who are active in clinical practice. This provides a key advantage as sponsors benefit from our physicians’ closeness to actual patient populations.
Investigator Contract Negotiation
A thorough, well thought-out contract serves to protect all parties involved. Each project provides unique opportunities and needs. From Indemnification to Intellectual Property to Subject Safety and beyond,ACORN CRO’s contracting department provides sponsors with expertise. We seek to protect the rights and business needs of all involved in an ACORN CRO project as we strive for the ultimate success of all participating parties.
Investigator Grant Management
Expedient, accurate grant management is essential to keep sponsors pleased and top-notch investigators and their sites engaged in the research process. Performance management is a key component ofACORN CRO’s Investigator Grant Management strategy. We seek timely, complete, accurate data with queries resolved for our sponsors, and our grant policies reflect this commitment to excellence.
Flexibility is a hallmark of ACORN CRO. Dependent upon Sponsor preference, ACORN CRO can handle virtually all aspects of Sponsor trial needs internally or we can work with third parties to deliver the project. Our Project Managers assume leadership roles when working with vendors and provide oversight to ensure that performance standards as detailed in project agreements are met or exceeded. Throughout the entire process, the professional staff at ACORN CRO works cooperatively with multiple stakeholders.
Electronic Data Capture (EDC) System
ACORN CRO is dedicated to providing access to the leading data management systems in the industry in order to meet the needs of our sponsors and sites more effectively and efficiently. Because of the system’s web-based design, it can provide real-time data access and monitoring resulting in cleaner data. User-friendly, intuitive navigation results in high user acceptance ratings. Other highlights include:
- Satisfies all applicable FDA Regulations, including 21 CFR, Part 11
- Supports all Phases of clinical trials
- 24/7 (EDC) Support Center
- Comprehensive end-user training via eLearning
- Electronic Case Report Form (eCRF) development using Clinical Data Acquisition Standards Harmonization (CDASH) standards
- Seamlessly supports mid-study changes
- Electronic signatures
- Capability to export data into multiple formats
- Point of entry data validations
- Increased feasibility of communication between sites, CRA and Data Manager
- Greater cost-effectiveness compared to paper and other EDC systems
- Ad-hoc reporting
- Access to Clinical Trial Management Systems (CTMS) and Safety modules
CRF Design & Production
CRF development comes as second nature to ACORN CRO as advanced technological processes have always supported sponsor initiatives. Along with this technological expertise comes the benefit of working with seasoned professionals who know and understand the nuances of oncology. Their experience results in efficient, effective CRF design from the onset. Critical data presentation in readily discernable formats distinguishes ACORN CRO CRF design. This commitment to ease of use and interpretation extends from input at the clinic level with user-intuitive operations to sponsor-level scientific review.
Protocol and CRF Review
ACORN CRO provides biostatistical review of protocols, case report forms (CRF), and other study documents. Review of protocols includes consideration of the appropriateness of the biostatistical content, including consistency of objectives with study measures and planned analyses. It also includes evaluation of the completeness of biostatistical content, and the quality of scientific presentation.
Review of CRFs entails matching of CRF content to protocol and/or statistical analysis plans. It also includes evaluation of the nesting structure of the data as implied by the CRF.
ACORN CRO can produce random allocation sequences for multiple group designs, with specified proportions assigned to each group, and with the number of stratification variables allowed by the sample size. The allocation sequence can be generated in blocks, with varying block length to reduce the risk that assignment will be determined and known by research staff.
Analysis Plan Development
ACORN CRO can produce or assist in the production of statistical analysis plans (SAP) for studies of varying complexity. Typical SAPs are free standing documents with abbreviated study background, a complete description of raw and derived variables, and specification of all descriptive and inferential procedures to be conducted. The SAP also specifies scheduled interim and final analyses by accrual or calendar schedule, the assessment points (for repeated measures) and the cohorts to be included in each analysis. For intervention studies, the SAP generally includes table shells, definition of figures to be generated, and listings to be produced (TFLs). For observational and retrospective research, TFLs generally include labeling and description of tables without production of table shells.
Analysis and Interpretation
ACORN CRO has expertise in the application of a wide range of statistical methodologies, including the following.
- Descriptive analysis of continuous, count, categorical, and censored outcomes
- Comparison of group means (univariate, multivariate, and repeated measures analysis of variance)
- Multiple linear regression
- Multiple binary and multinomial logistic regression
- Ordinal regression
- Linear mixed models for assessment of longitudinal data
- Nonparametric, parametric, and semi-parametric survival analysis methods
- Covariance structure modeling, including path analysis and latent variable modeling
ACORN CRO can implement analyses appropriate to most research study designs, including single and multiple arm intervention studies. ACORN CRO can also interpret statistical findings across all these methodologies.
Study Design & Protocol Development
ACORN CRO can design studies that will meet a sponsor’s research objectives, and will compare the feasibility of alternative designs to maximize the return on the sponsor’s research investment. ACORNCRO can provide complete protocol development services. With basic research concept or background documents provided, ACORN CRO will develop a high quality protocol draft, revise following review and input from sponsor and key opinion leaders, and finalize a protocol suitable for submission to institutional review boards.
Sample Size Calculation
ACORN CRO can provide sample size estimation or statistical power analyses that account for the design and effect size assumptions of most research studies. This includes one or two arm studies, single stage and two stage designs, and those using continuous, binary, and censored endpoints. ACORN CRO can describe the sample size implications of a range of study assumptions, and present these findings in graphical or tabular format.
ACORN CRO provides consultation services related to a range of biostatistical activities. These include consultation regarding study design and analysis planning for intervention trials, prospective observational research, and retrospective studies. ACORN CRO also provides consultation regarding development of random allocation sequences, and strategies for balancing in nonequivalent control group designs. ACORN CRO consults regarding interpretation of statistical findings, and regarding exploratory analysis utilizing a range of statistical methodologies.
Medical & Scientific Writing
Study Reports for Phases I-IV
Study Reports developed by ACORN CRO are created by published authors experienced with nuances of the backside of publishing. Sponsors benefit from this added expertise as ACORN CRO authors know what crucial information editors require for publication. ACORN CRO Study Reports feature clear, concise writing accompanied by extensive tables of readily understandable, relevant information. These Study Reports facilitate a smooth transition to publication as they serve as the source documents for future manuscripts, book chapters, and presentations. “Thorough, high quality, and complete” describe these final reports for end of study accounting and prepublication.
ACORN CRO provides sponsors with unprecedented advantages with protocol development for both investigator initiated and industry trials. No one comes close to our knowledge regarding how research functions in a community-based private oncology practice. ACORN CRO’s ties to community-based oncology are the deepest and strongest in the industry. We know what will and won’t work – as well as how to overcome potential barriers during protocol development.
From the scientific side, sponsors benefit from our extensive knowledge of research design and statistics. ACORN CRO enjoys a leadership position with its methodology, adaptive analysis and statistical models.
ACORN CRO assists clients in developing protocols which meet the most stringent IRB review and high investigator acceptance. By understanding and speaking the language of community-based oncology, we are able to attract investigators who recruit patients who would not otherwise participate in research studies.
Medical and scientific writing consultations range from pre-study literature reviews to article placement for journals and all points in between. ACORN CRO’s depth of understanding and mastery of the increasingly challenging field of oncology provides an automatic head start for sponsors. When it comes to matters relating to oncology, we have no learning curve. This intimate familiarity with oncology from point of care to national reimbursement issues can help research and product teams on the sponsor side understand previous work so that they can put their current initiative in perspective.
ACORN CRO provides sponsors with a depth of expertise which extends from actual in-practice research operations to meta-analysis of results by PhD level researchers. The result is relevant information that meets the most stringent scientific review. Augmenting the data itself are visual representations of the material which provide more casual observers with a more immediate understanding than would otherwise be possible.
Scientific Publications and Presentations
The ACORN CRO scientific and medical writing team has developed abstracts, presentations, and scientific posters for all major oncology and supportive care conferences in the US and Europe. We know the governing bodies and what types of contributions they seek. From project development to presentation, ACORN CRO stands ready to assist sponsors with concept, analysis, writing, design, production, and actual presentation, if appropriate.
Confidently rely upon ACORN CRO for publications, book chapters, journal articles, and other written scientific contributions. ACORN CRO staffs its Medical Writing division with published PhD level authors who deftly navigate the content development process with an eye toward publication. Consummate professionals, each author approaches individual projects with a personal commitment to reputation excellence that simply cannot be achieved by using ghost writers or a pool of medical writers.
Integrated Safety/Efficacy Summaries
ACORN CRO’s Integrated Safety/Efficiency Summaries seamlessly combine professional knowledge, regulatory adherence, and technical expertise. This ability to integrate clinical and operational data into relevant documents provides sponsors with a consistent framework for relevant decision-making.
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