Detailed, thorough quality reviews are an integral part of the production lifecycle of a document, rather than a one-off step in the development process. Mistakes in a document can call into question the validity of the content or result in an incorrect interpretation of the data.
We have been embedded in the quality review space since 2004 providing medical editing and quality control review services for a wide array of regulatory documents.
Quality Control Review Services
Data Review
• 100% verification of all data against source documents
• Internal content consistency between between sections and across deliverables
Editorial Review
• Consistent application of general and/or company-specific style guides
• Adherence to document template (as applicable)
• General copy editing (grammar, punctuation, etc)
• Review of abbreviations, internal cross references, citations, etc.
• Internal consistency and clarity of messaging throughout and across deliverables
Complete Quality Review
• Data review
• Editorial review
Our Quality Control Review Therapeutic Areas
Therapeutic areas of expertise include, but are not limited to:
- Oncology
- Cardiovascular
- HIV/AIDS
- Ophthalmology
- Neurology/CNS
- Endocrinology
- Inflammation
- Hematology
- HCV
- Psychological conditions
- Immunology
- Pulmonary and respiratory
- Autoimmune disorders
- Anti-infectives
- Gastrointestinal diseases
- Vaccines
Benefits of Working with Our Quality Control Review Team
Global
Located across all US time zones, in the EU, and in India.
Highly Experienced
Our medical editing and quality control reviewers have an average of 6 years experience and most have advanced degrees. Their industry background includes CRO, big pharma, NIH, and JAMA.
Flexible
We are responsive to changes in workload, adapting to accommodate variable client demand.
Scalable
With access to a large pool of experienced resources, we can scale up as needed to accommodate any volume and/or workload.
Comprehensive
We perform a comprehensive top to bottom review of each document to ensure not only data accuracy, integrity, and consistency, but also to ensure an omnipresent consistency of message.
Quality Control Checklists
We use quality control checklists to ensure the quality and level of detail for each review is consistent within and across documents.
Quality Control Review Frequently Asked Questions
Can you manage last-minute, drop-in QR requests?
Yes, Kateric can definitely accommodate last-minute and drop-in requests on an as-needed basis.
How flexible is your process for not only last minute requests, but also shifts in timelines or cancellations of projects?
Kateric realizes that timelines shift and projects get cancelled. The shifting of timelines is a potential risk in any project; Kateric is very flexible and mitigates this risk through consistent project and resource management.
With our client-dedicated business model, resource availability and project status are consistently reviewed and updated, allowing us (in real time) to adapt and overcome any potential challenges, including timeline shifts.
If a project shifts out significantly, either accelerating or delaying timelines, we work with clients to map out a plan that would ensure both timely delivery and service continuity.
If a timeline shifted out, we would take steps to ensure (to the extent possible) the same person could re-engage on the project once it became active again; if timelines accelerate, we would provide as many additional resources as is necessary to ensure timeline integrity, maintaining a single point of contact with the study team.
Do you have internal QR SOPs or do you work within Sponsor Standard Operating Procedures (SOPs)?
Kateric has both internal QR SOPs and checklists that can be used and is also fully amenable to utilizing Sponsor SOPs and checklists.
Do you have your own QR checklists?
Are they specific to each deliverable type or review stage?
Kateric has general checklists that can be used for multiple deliverables and also has developed comprehensive checklists for individual deliverables/review stages as needed.
Do you review against Sponsor-specific style guides and standards?
Yes, Kateric resources are very flexible and accustomed to using different style guides (Sponsor, AMA, etc).