Therapeutic Focus

Clinical Ink serves many therapeutic areas in clinical trials.
Our solutions offer greater support for clinical research initiatives that prioritize:

SEE OUR STUDY SOLUTIONS

Systemic Lupus Erythematosus (SLE) Studies

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Conducting Lupus SLE (Systemic Lupus Erythematosus) clinical trials poses several unique challenges for both the sponsor/CRO and the research site.

Current Challenges with SLE Studies:
Sponsor / CRO Challenges:

  • Medical data review team needs immediate access to data in order to confirm Lupus diagnosis
  • Very high query rate with typical queries not being sent until weeks after the data is collected
  • Difficulty closing queries due to insufficient documentation
  • Long delay between patient visit and eventual transcription of data into EDC

Research Site Challenges:

  • Completion of multiple, often unfamiliar, structured diagnostic questionnaires (BILAG*, SLEDAI* and CLASI*), which require duplicative data entry
  • Accurate scoring/grading of symptoms based on current and previous findings
  • Ready access to previously recorded measurements needed to access current status
  • Very high query rate with queries related to weeks old patient data

The Clinical Ink Solution:

To address these challenges, Clinical Ink utilized the core technology of the eSource platform to create eLAS (electronic Lupus Assessment Suite).

eLAS compliments the site workflow, guides the investigator through the completion of the questionnaires, eliminates duplicative data entry and automatically suggests scores and grades based on the data entered. An eLAS visit begins with the completion of the Physical Assessment where SLE-related symptoms are recorded, triggering the completion of the required sections of the BILAG, SLEDAI and CLASI questionnaires. Rather than having to transcribe the same data in all three questionnaires, as is typically required, eLAS features direct data entry and flow the data between the three instruments, saving time and eliminating error. Data from previous visits are automatically displayed, providing the investigator with the context required to evaluate the patient’s current status. Real-time edit checks show potential inconsistencies between current and previously entered data. Because eLAS contains both the completed questionnaires and the required supporting documentation (medical history, concomitant medications, notes, joint counts, physician global assessment, etc.), sponsor/CRO medical data review teams can access the information remotely, in real time, and determine if the patient qualifies for the study. Finally, queries are dramatically reduced and those that remain have a higher close rate because of the abundance of supporting documentation. Using the eSource platform’s Targeted Source Data Review, eLAS can be configured to alert monitors and data reviewers when specific criteria are met, e.g. scores outside a given range or scores that differ from pervious scores by a specified amount.

(*BILAG – British Isles Lupus Activity Group; SLEDAI – SLE Disease Activity Index and CLASI – Cutaneous Lupus Erythematosus Disease Area and Severity Index)

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Central Nervous System (CNS) Studies

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Conducting Central Nervous System (CNS) studies (autism, AD/HD, MS, Parkinson’s disease, Alzheimer’s disease, schizophrenia, depression) in clinical trials creates several unique challenges for both the sponsor/CRO and the research site.

Current Challenges with CNS Studies:

Sponsor/CRO Challenges:

  • CNS Surveillance teams need immediate access to data in order to confirm varied enrollment criteria for CNS studies
  • Very high query rate, with typical queries not being sent until weeks after the data is collected
  • Difficulty closing queries due to insufficient documentation
  • Long delay between patient visit/assessments/questionnaires and eventual transcription of data into EDC
  • Inability to hear how varied assessments/scales/questionnaires were administered by site staff

Research Site Challenges:

  • Completion of multiple, often unfamiliar, questionnaires (Wechsler Abbreviated Scale of Intelligence (WASI), Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Behavior Rating Inventory of Executive Function (BRIEF), as examples) which require duplicative data entry
  • Accurate scoring/grading based on completion of questionnaires (manual grading/scoring)
  • Ready access to previously recorded measurements needed to access current status
  • Very high query rate with queries related to weeks old patient data
  • No way of recording (audio) the administration of varied CNS related assessment and tying them to the completed assessments

In order to address these challenges, Clinical Ink utilized the core technology of the eSource platform to deploy CNS related assessments, questionnaires and scales, along with the collection of other protocol mandated clinical data, to provide a central location for the collection of all data.

The Clinical Ink Solution:

Capture compliments the site workflow, guides the investigator through the completion of the questionnaires, eliminates duplicative data entry by allowing for direct tablet entry of data and automatically calculates scores and grades based on the data entered. A CNS visit begins with the completion of the necessary clinical trial protocol data (informed consent, eligibility, medical history, physical exam, etc.). From here, the CNS-specific questionnaires, scales and assessments are carried out. Rather than first capturing all this data on paper scales or questionnaires and assessments, the research site staff enters the data directly in the Capture tablet, saving time and eliminating error. Data from previous visits can be automatically displayed, providing the research site staff and sponsor/CRO surveillance teams with the context required to evaluate the patient’s current status. Because Capture contains both the completed questionnaires and the required supporting documentation (medical history, concomitant medications, notes, etc.), sponsor/CRO teams can access the information remotely, in real time, and carry out remote monitoring activities with little to no Source Document Verification (SDV) required. If audio is needed for the assessment, the Capture application allows for audio recording. The audio recording is embedded with the assessment data and allows sponsor/CRO teams the ability to listen to the administration of the assessment along with the collected data. Sponsor/CRO surveillance teams are able to complete review forms and send these reviews back to the site to help the sites improve their administration techniques. Finally, queries are dramatically reduced and those that remain have a higher close rate because of the abundance of supporting documentation.

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