Catlett Hematology Advisory Services provides consulting for clinical trial development, adverse hematologic event mitigation, case reports or case series review, manuscript editing prior to submission for publication, and examination of medico-legal and forensic cases.

 

Clinical trial and drug development

The development of drugs and biologicals for any indication requires carefully designed clinical trials and expertly crafted protocols. These elements improve the rapidity with which promising therapies are brought to market and made available to patients in need. With our broad experience in clinical research, we will work directly with you during the conduct of your clinical trials. 

We offer advice on a variety of issues, including hematologic monitoring strategies that can decrease the burden of unnecessary blood draws, clinic and travel time, and laboratory expense; appropriate endpoints; and appropriate management of severe unexpected serious adverse events (SUSAR’s).

To assist our clients in these endeavors, we can also review and edit the following documents:

  • Protocol and Synopsis

  • Protocol Amendments

  • Informed Consent Forms

 

Hematologic adverse event mitigation

Catlett Hematology Advisory Services offers advice on any product in development, regardless of indication, which may have an incidental or expected off-target hematologic event.  We do not limit our guidance to agents that treat only benign or malignant hematologic or oncologic conditions.

Once an adverse event has been identified, a detailed review of case report forms or other data sources will be performed to determine etiology and attribution. We will also assist with monitoring and mitigation policies that may be mandated by the U. S. Food and Drug Administration or other regulatory bodies.

 

Review of case reports or case series 

A case report or case series will be analyzed for appropriateness of diagnosis and treatment, completeness of literature reviews, and trends in outcomes. Assistance with editing the written report is also included.

 

Editing of manuscripts prior to submission for publication in scientific journals

We have extensive experience with the writing and editing of manuscripts for publication. We will add conciseness and clarity in creating a manuscript that is submissible for publication in peer-reviewed, high-impact journals.

 

Consultation in medico-legal and forensic cases

We will examine medico-legal cases having a specific hematologic aspect or question and offer advice regarding the appropriateness of treatment, outcome, or another issue. We will also consult for forensic issues. Acceptance of these cases is subject to approval on a case-by-case basis. Please note: we do not offer ‘expert witness’ services or clinical second opinions for individual patients.

 

Catlett Hematology Advisory Services can be retained at an hourly rate or a retainer fee. Contact us for more information.

Located in the District of Columbia, close to the U. S. Food and Drug Administration, the National Institutes of Health, and regional academic centers.