Critical Path Research

Functional Service Provider

Who Are We And what do we do ?

Let our highly skilled professionals with decades of combined experience put you on the straight path with any aspect of clinical research.

This is what we can do for you in the timeframe required:

AUDITING/QA: Data, CRO-Sponsor fulfillment, Laboratory compliance, for-Cause, Surveillance
DOCUMENT DESIGN: design, creation, writing, edits: SOPs, Protocols & Amendments, eCRF
FDA/IRB SUBMISSIONS: IND, NDA, Final Reports, essential document site bundling
MEDICAL WRITING: Protocol and Amendments, SOPs, Pharmacy & Lab Manuals, ICF, IB, Raci matrix, Gantt charts, IB, Statistical composition
MONITORING: all of types: 1st Time Review, reclaiming, risk-based strategies
REGULATORY EXPERTIESE: Collections, Surveillance, Submissions
REGULATORY EXPERTIESE: Collections, Surveillance, Submissions
STUDY START UP: CTA, Recruitment PI verification, questionnaire creation, retrieval & evaluation, essential document retrieval, storage & updates
TRAINING: All Site GCP and CFR compliance, study site procedures and processes for 3rd party Audits, Sponsor appropriate Form production

Therapeutic Areas in Phases I - IV:

Oncology
Neurology
Cardiology
Respiratory
Endocrinology
Surgical
Special Senses

We are well aware of corporate customs in clinical research and we excel at navigating the sometimes arduous twists and turns on the path for an ordered and quantified outcome

CPR will always be available in an advisory capacity to respond to your questions and issues. Our goal is to make your group autonomous well beyond the scope of your project.

Monitoring & Reclamation

Whether you are in need of a first-time data monitoring team or trying to rescue incomplete data from previous reviewers, we can jump in at any stage and get the job done.

Our inimitable reputation makes us the perfect choice for first time review of data OR as a SWAT Team rescue involving a project in distress.

Our turnaround time will be met masterfully, comprehensively and in compliance with all regulations.

Auditing

Audits should not be an imposition, but the culmination of all your training and experience, that reflect implementation of both FDA regulations and GCP Guidelines.

Even as an avid clinical researcher there will be times when you need support with the planning, preparation and implementation for the Big Day
.
We can prepare you, train you or take over the reins and ensure that your processes, procedures, and data are in audit ready condition.

Medical Writing

From start-up activities to closing assessments and more, documents, manuals, and guidelines are always in need of creation, revision, and modification.

Our experienced medical writers are effective at what they know and how they write, which is reflected in the content, style and versatility of each composition.

They are meticulous, organized and tenacious with decades of experience in almost all therapeutic areas and indications, as well as FDA mentoring and preparation for IND and NDA submissions.

Training

Historically speaking, site training tends to be needlessly complex, poorly organized, & unreasonably long, so much is overlooked before long.

We specialize in making training effective and short, with directives as to where to find the detail.

We can help your staff better understand the “required” code of Federal Regulations and the ICH-GCP Guidelines as is required in all phases of Clinical Research

If you give a man a fish, he eats for a day. If you teach that man to fish, he eats for life !!!!.