top of page
Open Laptop

Services

Protocol Guidance - Rater Training - Support - eCOA

Services : Services
Implementation Planning

Guidance

A Comprehensive Approach

We provide guidance on formulating a standardized training protocol, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection. We provide:

​

  • Guidance on outcome measure selection

  • Formulation of standardized training procedures, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection.

  • Advise on training equipment and needs for individual sites to ensure a standardized protocol while keeping the practicality of testing in mind

  • Creation of an abridged training resource for quick reference for in-study support

  • Guidance in the development of a training video (script, protocol adherence, quality assurance, content, etc.) that outlines the study’s testing protocol as a supplemental resource as needed

Finance Consultancy

Rater Training

Expert Instruction

We utilize Physical Therapists who are educated, knowledgeable, and experienced in the use of clinical outcome assessments to train, evaluate, and certify each clinical evaluator individually. Our training methods highlight study specifics to ensure the most accurate grading of the outcome assessment. Our training includes:

​

  • Didactic and practical hands-on training recognizing each individual’s style of learning to maximize the evaluator’s ability to accurately and consistently perform the outcome assessments

  • Applied skills assessments and in-person or remote web-based training/re-training and certification for sites as needed to ensure standard administration of sponsor protocol

  • Certification for each CE trainer that has adequately demonstrated skills to implement testing 

  • Site initiation visits (SIV) and Investigator Meeting (IM) Training/Certification

Woman on Phone

Support

The Path to Success

We continue to be â€‹accessible as a remote resource for clinical evaluators for questions or guidance throughout the study. We provide:

​

  • Live or remote re-training of clinical evaluators

  • Tracking of re-certification requirements throughout the duration of the study 

Image by Dylan Ferreira

                            eCOA

Electronic Clinical Outcome Assessment 

Rater Training and Support - Anytime, Anywhere

​We are experienced in the technology and procedure to remotely assess patients, train CEs, or provide feedback of recorded assessments resulting in more granular endpoint data. We offer:

​

  • Quality control of outcome assessment data via video review of in-clinic assessments to ensure proper compliance with standardized testing practices

  • Remote assessment of clinical evaluators’ ability to perform the clinical testing to ensure a standardized testing environment and adherence to protocol

  • Remote assessment of patients 

While we maintain a robust internal reference of scales and measures our deep expertise in COAs allows us to effectively train and certify raters on any assessment. We are experienced with utilizing a wide range of commonly used COAs (see below), and we would be happy to provide a tailored list of scales relevant to your study area upon request. 

​

  • 2-Minute Walk Test (2MWT)

  • 30 Second Sit to Stand Test

  • 6-Minute Walk Test (6MWT)

  • 9-Hole Peg Test

  • Berg Balance Scale

  • CMT Neuropathy Score (CMTNS)

  • Dynamic Gait Index (DGI)

  • Functional Gait Assessment (FGA)

  • Functional Reach Test (FRT)

  • Grip Strength Dynamamotery

  • Hammersmith Functional Motor Scale - Expanded (HFMSE)

  • Hand-held Dynamometry (HHD) Digital MMT

  • Manual Muscle Testing (Kendall Muscle Grading)

  • Mini Balance Evaluation Systems Test (Mini BEST)

  • Modified Friedreich Ataxia Rating Scale (mFARS)

  • Myasthenia Gravis Activities of Daily Living Scale (MG-ADL)

  • Myasthenia Gravis Composit (MGC)

  • North Star Ambulatory Assessment (NSAA)

  • Performance Oriented Mobility Assessment  (POMA)

  • Quantitative Myasthenia Gravis Score (QMG)

  • ROM Goniometry

  • Romberg Test

  • Scale for the Assessment and Rating of Ataxia (SARA)

  • Single Leg Stance Test

  • Spirometry Testing: Forced Vital Capacity, Resting Vital Capacity

  • Time to Stand

  • Timed "Up and Go" (TUG)

  • Timed 25-Foot Walk (T25FW)

  • Timed Up & Go Test (TUG)

  • Unified Parkinson’s Disease Rating Scale (UPDRS)

bottom of page