The Importance of Clinical Project Management and Process

clinical project management
clinical project management

Companies providing clinical project management services specialize in pre-clinical project management and or one specific phase of research, while others provide project management services throughout all phases of clinical trials. 

Vial leverages the abilities and resources of our site network in conjunction with turnkey Dermatology CRO management to provide sponsors with fully integrated service capabilities.

This article will help you learn more about the importance of Vial’s comprehensive project management services.

Project Management Process

With extensive experience in all phases of dermatology studies, our contract research organization (CRO) and project managers will ensure sponsors receive the flexible and reliable support they require. 

Our comprehensive project management services provide:

Strong Communication

Our dermatology CRO Project Manager (PM) is the primary contact for clinical trials. It is the responsibility of the PM to ensure that all communication channels remain open and effective for the entire duration of the dermatology study. The PM will effectively facilitate:

Routine Communication

We complete all routine communication through:

  • Weekly (or other predetermined frequency) reports on non-significant issues and concerns
  • Study updates via Weekly Status Reports
  • Teleconference calls

The PM will attend face-to-face meetings and communicate via email or telephone.

Urgent Communication

We facilitate open channels for urgent communication and provide support for:

  • Time-sensitive issues pertaining to the investigative site
  • Subject eligibility issues and questions
  • Safety concerns
  • Site audit concerns
  • Vendor management and IP related issues

Proper communication helps identify and resolve risks that may jeopardize a dermatology trial. 

Timelines

Timelines are essential for a dermatology study and any clinical trial. Vial maintains an up-to-date timeline from each study’s initiation. Timelines are carefully tracked daily and discussed during meetings with sponsors. 

Should milestones and deliverables change during the execution of the project, the timeline will be updated accordingly to reflect all changes. All changes to major milestones are tracked and submitted to the sponsor for approval. 

Vendor Selection

Vial understands that proper vendor selection is crucial to ensure the success of a dermatology study. We work closely with qualified vendors such as labs, photography, ECG, EDC, and biometrics providers. 

Site Selection

Site selection is important in ensuring that only qualified and experienced sites are selected to enroll subjects based on inclusion and exclusion of a study’s protocol. 

Study Training

Study training is essential to ensure all participating vendors and clinical sites are trained in each study’s protocol. 

Monitoring 

Consistent monitoring is crucial to ensure that a study’s protocol is followed and subject safety standards are maintained. Monitoring includes interim monitoring visits and report delivery to the sponsor as defined in the monitoring plan, which is determined by the PM and sponsor. 

eCRF Data Verification

CRF collection occurs during monitoring visits. Each CRF reviewed and collected is documented in the monitoring visit report. All CRFs will be source data verified. 

Status Tracking

Status tracking of study events is reported in the Weekly Status Report. Our dermatology CRO also tracks pass-through costs, such as advertising spent by each site, investigator payments, and vendor payments. Pass-through costs are sent throughout each study as invoices. 

Risk Management and Contingency Plans

Uncertainties may arise during a dermatology study that can impact timelines, budget, and deliverables. To address these, the PM identifies common risks associated with the study and drafts associated actions and contingency plans. 

Study Close-Out

A dermatology study close-out occurs when all subjects have been considered completed or terminated early, all CRFs/eCRFs have been collected and entered, and all data management activities are complete. A study close-out will follow with the following:

Database Lock

After the necessary corrections have been made to the database it is prepared for lock. Once this occurs, no changes to data can be made. 

Site Trial Close-Out Visits

After completing the database lock, close-out visits are scheduled and conducted according to the study timeline.

About Vial:

Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.