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Clinical Operations

Tailored solutions that align with your study objectives, timelines, and budget

We are agile and flexible, seamlessly integrating with your team to successfully achieve your product development goals.

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KEY FIGURES

30+

Years of experience

50%

Studies related to rare diseases

30%

Studies for medical devices​

A personalised, flexible and comprehensive offerings

A full-spectrum service from support your study design to authoring the clinical study report, with respect to your budget and not compromising with the highest standards of quality and patient safety.

State-of-the-art technologies

Vision, our SaaS tech-enabled solutions offer a set of proprietary clinical trial tools such as CDMS, CTMS, ePRO, eTMF to facilitate the efficiency, accuracy, and safety of clinical trials.

Patient-centric clinical operations

Our clinical operations are designed to tailor each interaction to individual patient needs, ensuring compassionate and patient-focused care. ​

Our goals are to ensure that meaningful outcomes are considered with an understanding of the patient journey.

FAQs

What are the major milestones of each clinical trial?

Clinical trials typically go through several key milestones, but specific details can vary based on the type of trial and the therapeutic area.

 

Here below are the critical steps for a clinical trial:

 

1. Study design & Protocol authoring are essential to define study objectives and ensure alignment with the clinical development plan.

2. Study feasibility will help to assess whether the study is viable in terms of timelines, targeted population, and help to fine tune the regulatory strategy.

3. Regulatory Approvals need to be obtained before starting any patient recruitment activities and help to ensure that the study is ethical and meet safety standards.

4. Study conduct which encompasses monitoring and data collection.

5. Study Completion once all patients are completed and final data collected as planned per the protocol.

6. As the final step, data analysis and reporting during which collected data are analyzed and a clinical study report is prepared.

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How to increase patient retention in a clinical trial?

To enhance patient retention in clinical trials, sponsors need to:

 

1. Ensure clear and ongoing communication, building trust between patients and site staff.

2. Create a patient centered project that focuses on their needs and concerns.

3. Educate patients on the study’s benefits and their role in developing product knowledge.

4. Facilitate patient’s journey and streamline procedures to minimize the burden on patients and utilize decentralized technologies for remote data collection.

5. Provide ongoing education about the study’s progress to maintain patient engagement.

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What are particularities of clinical trials in rare diseases?

Clinical trials for rare diseases present unique challenges due to the limited number of patients and limited existing knowledge on the disease.

 

Recruitment difficulties often arise, requiring involvement of patient associations. Patient advocacy groups play a crucial role in raising awareness and facilitating study participation.

 

Regulatory agencies may offer incentives, such as orphan drug designation, to encourage research in rare diseases.

 

Flexibility in study design and endpoints are necessary to overcome the heterogeneity in rare diseases. Adaptive trial designs allow for real-time adjustments based on new data.

 

Patients need to be empowered and patient-reported outcomes gain significance in assessing treatment efficacy.

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Related Glossary

Individual Patients 
Endpoint
Surrogate end point
Adverse Clinical Event (ACE)
Biometric data
Clinical Study Report (CSR)
Consent
Good Clinical Practice (GCP)

Questions? Get the answers by our expert team ​

No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.​