Finding experienced resources to register and report your clinical trial or locating the right team for end-to-end management and support of an entire portfolio of studies can be difficult.
Our Clinical Trial Disclosure (CTD) experts are here for you.
Our dedicated team of disclosure experts have successfully registered thousands of studies across multiple registry platforms and therapeutic areas.
Let our seasoned project managers and authors navigate you through the ever-evolving clinical trials disclosure landscape.
Met our timeline with no NIH comments
“This was a complex registry posting with a tight turnaround time.
The author and the project manager did a great job of managing the project to meet
our timeline, AND the record posted with NO NIH comments. Thank you!”
Clinical Trial Disclosure Client
Clinical Trial Disclosure Services
Management Consultation
Kateric provides management consultation services in which we leverage our subject matter expertise and guidance to help you understand, interpret, and apply relevant legislation and regulations. Services include but are not limited to:
- Regulatory guidance
- Education and training
- Disclosure audit/gap analysis
- Client process development and documentation
Protocol Summary Registration
Kateric provides resources and guidance in support of protocol summary registration and applicable maintenance activities (e.g., monthly and annual updates) as needed.
Our vast protocol summary registration experience includes but is not limited to the following individual registries:
- ClinicalTrials.gov
- EudraCT
- ENCePP
- Individual country registries
- Client-specific registries
Clinical Trial Results Reporting
Kateric provides resources and guidance in support of clinical trial results reporting.
Our highly experienced resource team has authored thousands of clinical trial results postings across the following individual registries:
- ClinicalTrials.gov
- EudraCT
- Individual country registries
- Client-specific registries
Document Redaction
Kateric provides resources and guidance in support of document redaction activities.
Applying industry standards (e.g., Transcelerate) and client-specific guidelines, we have redacted hundreds of documents across the following types of requests:
- Policy 0043 (EU Access to Documents)
- Policy 0070
- Third Party
- Final Rule
- Publications
Plain Language Summaries
Kateric provides resources and guidance for authoring of plain language summaries.
We have developed a document template and an accompanying process that can be used as clients work towards becoming compliant with this new European Union regulation (EU No 536/2014) in advance of it becoming mandatory.
Questions about clinical trial disclosure?
Meet Your Clinical Trials Disclosure Team
Mary Culliton
Founder and President
Janice Worley
CTD Subject Matter Expert
and Project Manager
Sophia Flowers
Business Operations Manager
Industry knowledge and regulatory expertise
“We have really enjoyed working with Kateric. Working across multiple departments
within our organization has been a huge benefit and their industry knowledge and
regulatory expertise have been invaluable.”
Clinical Trial Disclosure Client
Frequently Asked Questions
What industries do you specialize in?
We specialize in providing clinical trial disclosure services to pharmaceutical/biotech companies of all sizes (including small, mid-size, and big pharma), as well as contract research organizations and academia.
How are you successful in the disclosure space?
Highly experienced and client-dedicated resources
The depth and breadth of experience in our resources comes from being embedded in the disclosure space since it's inception, authoring thousands of records across multiple registries.
Being client-dedicated means utilizing the same resources over the life of a contract providing continuity of service and fostering a long-term relationship with a mutual investment in the end result. We feel as equally invested as our clients in the process and overall achievements.
High quality of our deliverables
Through the use of a documented and systematic approach that builds quality into the document as it evolves through the lifecycle, 90% of records authored by Kateric are made public with no regulatory review (NIH) comments, which is much higher than our competitors and has the added benefit of reducing the overall cost of the record.
Collaborative and transparent working relationships
It’s a way of thinking that is ‘we’ and not ‘us’ and we believe in it.
We are highly visible to clients and offer a great client experience, developing long-term partnerships; our average client partnership is 5 years.
Through the use of an online client dashboard, our clients can see the status of each project at any given time. We integrate seamlessly with client teams, working side-by-side, embedding in the company culture and transmitting that in our day-to-day work.
Value maximization
We have found that our extensive experience and resulting efficiencies gained from the Kateric operational model and superior quality result in lower cost to clients.
What is your clinical trial disclosure registry workflow?
We have mapped out an integrated process, with all documentation, governance, and infrastructure needed to enable immediate startup of any disclosure project.
The use of detailed step-by-step process maps, guidance documents, document templates, and other job aids ensures consistency, quality, and adherence to applicable regulations.
We work with each client to tailor and individualize the process and all accompanying documentation to accommodate any additional client specifications.
FINALIZE
- Obtain final approval
- Upload to registry
REVIEW
- Multiple internal reviews for both content and quality
- Subject matter expert reviews to ensure compliance with applicable registry guidelines
ENGAGE
- Early engagement of study team
- Solicit and incorporate study team input, confirming alignment with study details
Identify & Report
- Review materials to identify applicable reportable information
- Prepare compliant registry record
How have you responded to the evolving clinical trial disclosure regulations?
(e.g. NIH Final Rule, Clinical Trial Regulation EU No 536/2014)
Having been entrenched in the disclosure space since 2007, Kateric recognizes that the recent increase in legislation broadening the scope of required transparency can be a challenge to navigate as you work to stay compliant while balancing your commercial obligations.
In response to this Kateric has developed a management consultation program as a complement to our clinical trial registry authoring and redaction services. Through this program we provide expert consultation and guidance to help with understanding, interpreting, and applying the relevant regulations to individual programs and studies.
Our subject matter experts work with clients to help them determine what studies need to post, by when and to which registries, as well as what additional documentation (if any) may be needed to complete the registrations. We also provide guidance as to which studies may be eligible for extensions in reporting (i.e., Certification of Delay on Clinicaltrials.gov), assisting with the requests, as needed.
In addition, our expertise can be leveraged to conduct a gap analysis to identify any potential deviations in compliance, providing what support is needed to bring each study into full compliance.
We have gone a step further by developing comprehensive education and training, which can be implemented in a single department or across an entire client organization as needed to develop disclosure policies and processes. We work with clients to develop individual training plans based on their business needs. The training includes (but is not limited to) process training, author training, and study team or internal stakeholder education.
Finally, we remain embedded and actively involved in the clinical trial disclosure community, so that we can remain abreast of changes, incorporating them into our processes and informing our clients as needed.
What are your standard timelines for protocol and results registry postings?
The overall process can be highly variable and dependent on multiple factors. As a result, our process timeline is flexible and can be modified to accommodate individual client needs such as study priority, team bandwidth, or other company needs, including compression of timelines to meet imminent compliance deadlines.
What is a client-dedicated resource and how is that an advantage?
Being client-dedicated means a static team of resources is assigned to a client for the life of the contract, with each resource working only for a single client at a time.
These resources work side-by-side with the study teams throughout the development of each deliverable. Over the longer term, the resources often become embedded in the culture of the company, building and establishing relationships with a mutual investment in the end result. Knowing a company's internal culture and how they operate on a day-to-day basis translates to gained efficiencies with enhanced communication and team interactions. It also makes you feel like you are working with the colleague down the hall. In the end, this helps projects run smoothly, ultimately facilitating timely completion.
Outstanding quality, timelines, and communication
“The Kateric author was outstanding, in terms of quality, timelines, communication,
understanding the big picture and details, proactivity, and output.”
Clinical Trial Disclosure Client
Our Typical Clinical Trial Disclosure Clients
Are Those That Need:
internal disclosures department
Client with limited internal clinical trials disclosure resources who need to outsource all clinical trials disclosure activities
Author support
Clients who need to outsource individual clinical trials disclosure components as an augment to existing internal clinical trials disclosure resources
Short-term
ad-hoc support
Clients who need to outsource individual clinical trials disclosure components in support of an individual project