Mail Us

bd@bioexcelife.com

Call Us

(+91) 974 2291 095
(+91) 976 6619 176

Clinical Trials

Clinical Trials

Bioexcel offers

Clinical Trials

Clinical Trial
End-to-End Clinical Trial Services for Medical Devices

At Bioexcel, we understand that clinical trial for medical devices require a unique approach. Unlike multi-phase drug or vaccine development, medical devices demand tailored clinical evidence to demonstrate safety, performance, and usability. As a specialized Contract Research Organization (CRO) for medical devices, we provide comprehensive trial management services that help you navigate the complexities of global regulations and bring your innovations to market.

How Bioexcel Stands Out as a Medical Device CRO

Medical device trials differ significantly from drug or vaccine trials. Instead of multi-phase clinical development, devices require clinical evidence to assess performance, safety, and usability under real-world conditions. Here’s how Bioexcel is uniquely positioned to support medical device manufacturers:

  1. Performance-Driven Evidence: We focus on proving device functionality, safety, and clinical performance in real-world settings, adhering to ISO 14155 and MDR requirements.
  2. Human Factors and Usability: Device trials involve usability testing to ensure the product is intuitive and effective for end-users.
  3. Iterative Design Validation: We incorporate iterative testing, allowing for design modifications during trials, which is uncommon in drug trials.
  4. Regulatory Expertise: Extensive knowledge of device-specific requirements like Clinical Evaluation Reports (CER), Post-Market Clinical Follow-Up (PMCF), and risk-based trial designs.
  5. Tailored Protocols: Our trial designs address the specific needs of devices, such as functionality for implants, diagnostic accuracy for IVDs, or wound healing for sutures and hemostats.
Clinical Trial

Our Medical Device Clinical Trial Services

Clinical Trial Design and Protocol Development

Custom Strategies for Accurate Results

We design device-specific protocols that align with your objectives, intended use, and regulatory requirements.

Key Features:

  • Performance- and safety-focused endpoints.
  • Usability studies for human factors validation.
  • Compliance with ISO 14155, FDA, and MDR standards.

Feasibility Studies and Site Selection

Laying the Foundation for Trial Success

We identify suitable sites and investigators with expertise in device-specific trials to ensure optimal trial execution.

Key Features:

  • Investigator and site qualification.
  • Infrastructure assessments for device testing.
  • Patient population analysis.

 

Regulatory Submissions and Compliance

Streamlining Approvals for Trial Initiation

Our team ensures your clinical trial meets global compliance standards with precise and timely submissions.

Key Features:

  • Preparation of Clinical Trial Applications (CTA) and Investigational Device Exemptions (IDE).
  • Communication with regulatory bodies (FDA, CDSCO, EMA, etc.).
  • Support for ethics committee (IRB/IEC) approvals.
In Vitro Diagnostic

Post-Market Clinical Follow-Up (PMCF)

Ensuring Long-Term Safety and Compliance

We design and execute PMCF studies to monitor device safety and performance in real-world conditions post-approval.

Key Features:

  • Real-world evidence (RWE) collection and analysis.
  • Preparation of Periodic Safety Update Reports (PSUR).
  • Long-term monitoring for implants and high-risk devices.

Case Studies

Case Study 1: Ophthalmology – Clinical Trial for an Intraocular Lens

Challenge:

A manufacturer of a premium intraocular lens (IOL) needed to validate visual outcomes and patient safety in a multicenter trial.

Solution by Bioexcel:

  • Designed a protocol focusing on safety, visual acuity improvement, and patient-reported outcomes.
  • Recruited ophthalmologists with expertise in cataract surgeries across five sites.
  • Real-time monitoring of post-operative complications and visual performance data.

Outcome:

  • Demonstrated a 30% improvement in visual acuity for participants.
  • Successfully submitted the trial data for CE marking under MDR.
Quality Assurance

Case Study 2: Orthopedics – Trial for a Novel Joint Implant

Challenge:

A company developing a Class III knee implant required a trial to assess biomechanical performance and patient outcomes.

Solution by Bioexcel:

  • Conducted biomechanical and usability testing before trial initiation.
  • Selected leading orthopedic centers with experienced investigators.
  • Monitored patient recovery and implant performance over 12 months.

Outcome:

  • Achieved 95% patient satisfaction and no major adverse events.
  • Provided evidence supporting regulatory approval in the EU and the US.

Case Study 3: Sutures – Comparative Study for an Antibacterial Suture

Challenge:

A startup producing antibacterial-coated sutures needed clinical evidence comparing infection rates with traditional sutures.

Solution by Bioexcel:

  • Designed a randomized controlled trial comparing infection rates in surgical patients.
  • Collaborated with surgeons across three hospitals for robust data collection.
  • Provided detailed statistical analysis of infection and wound healing rates.

Outcome:

  • Demonstrated a 40% reduction in post-surgical infections.
  • Enabled successful market entry in both EU and Asia.

Case Study 4: Hemostats – Validation of a Topical Hemostatic Agent

Challenge:

A manufacturer needed to validate the safety and efficacy of a topical hemostatic agent for use in vascular surgery.

Solution by Bioexcel:

  • Designed a multicenter trial focusing on time-to-hemostasis and patient safety.
  • Conducted training sessions for surgeons to standardize device application.
  • Monitored adverse events and hemostatic performance in real-time.

Outcome:

  • Reduced bleeding time by 50% compared to standard practices.
  • Provided data supporting FDA 510(k) clearance.

Why Partner with Bioexcel?

Specialized Device Expertise

Experience in Class I, II, III devices, including IVDs and combination products.

Regulatory Mastery

Extensive knowledge of ISO 14155, MDR, FDA, and CDSCO requirements.

Real-World Focus

Expertise in collecting clinical evidence for device performance, usability, and safety.

Global Reach

Proven success in managing multicountry trials with diverse patient populations.

Quality Assurance
Help & FAQ

Frequently Asked Questions

Medical device trials focus on demonstrating safety, performance, and usability rather than pharmacokinetics or dosing, as in drug trials. Device trials also often involve fewer phases but require iterative design validation and real-world testing.

Yes, we have extensive experience managing multicountry trials, ensuring seamless coordination and regulatory compliance across regions.

We adhere to ISO 14155, FDA, MDR, and ICH-GCP guidelines, ensuring all trials meet the highest ethical and regulatory standards.

At Bioexcel, we bridge the gap between innovation and market success with tailored clinical trial services for medical devices. Contact us today to ensure the safety, performance, and compliance of your device.