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We turn challenges in clinical research into solutions

We work with people and for people in clinical research industry by ensuring that Sponsors meet their projects' milestones and targets. Our purpose is turning challenges into impactful solutions for all patients through educational and supportive services. We provide efficient and prompt remote, onsite, hybrid monitoring for GCP compliance, PI site assistance, source data verification, safety reporting, TMF management, informed patient qualification and retention. We adhere to GCP, HIPPAA and GDPR guidelines.

Services

Solution-focused brief counselling for clinical industry

We offer solution-focused counselling for patients and family members as part of clinical research projects destinated to patient-participants.

Even though mental health support had been identified as a gap in clinical programs, Sponsors refrain from offering/referring to such predominantly due to regulatory and ethical concerns. Solution-focused counselling adds value to clinical research by outlining patients' resources when time, scope, or regulation limit deeper interventions. It stays within the span of educational and supportive services. Yet, it is a powerful tool for promoting positive change in challenging prolonged therapies or life circumstances. Solution-focused brief counselling originate from social work practice (often in situations of crisis). It builds on improvements, signs of progress and participants' goals and hopes. It favours patient motivation by personalizing the change context. Being a short-term approach, it is cost-effective and clients' successes are easy to track.

For example instead of asking: “Why haven’t you been taking your meds? SFBC practitioner might ask:
“Tell me about a time when you were able to stay on track—what was working for you then?”
“What would it look like if it became just a little bit easier to take your medication every day?”

Services

Индивидуално консултиране

Remote, risk-based & on-site monitoring for clinical studies in phase IIIb to IV

Trained CRA with experience in virtual collaboration. Monitoring of trial data, compliance, and site performance through digital platforms with or without physical site visits.

Services include:

  • Source data verification (SDV)
  • Ongoing risk-based monitoring
  • Safety event tracking documentation review and reporting
  • Remote/on-site validation of regulatory binders, ICFs, logs
  • Drug accountability checks
  • Site staff training and protocol adherence checks
  • Protocol deviations tracking
Solution-focused counselling for family members

Solution-focused counselling for family members

Caring for a loved one with a long-term or life-limiting illness can be deeply challenging. We offer solution-focused counselling sessions to family members, aiming to support hope, clarity, and resilience — even in difficult times. Who may benefit: spouses or partners, parents or adult children, close relatives or long-term caregivers.

Format: One-on-one or couple/family conversations

Duration: 30–45 minutes

Location: In person or via secure video call (Webex, Healee)

Short-term, goal-oriented conversations focused on:

  • What’s working (even if "the tiniest")
  • What gives you strength
  • What small, helpful changes are possible
Консултиране на тийнейджъри

One-on-One Sessions

As a commitment to participants' well-being, we offer access to short, structured one-on-one conversations based on the principles of Solution-Focused Brief Conversations (SFBC). These are not psychotherapy sessions, but optional supportive meetings intended to help patients to reflect on their own resources, strengths, and goals during or afterr the study or PSP period.

Format: One-on-one, confidential conversation with a trained facilitator (not part of the clinical research team)

Duration : 50 minutes sessions (or as per SoW 20, 30 min)

Location: Online (via secure video platform-Webex or Healee), in-person

Content: Discussions may include:

  • What is going well for you right now?
  • When do you feel most in control or hopeful?
  • What small steps have helped you move forward in the past?

Useful links

Reach out to us

Please reach out to us for a tailored to your program solution.

Contact

Address: 1, Vitosha Blvd., Entrance A, office 150, Sofia 1000, Bulgaria

Telephone: +359 988 387 775

E-mail: mm.praxis.llc@gmail.com

Bank details: MM PRAXIS LLC, First Investment Bank, IBAN: BG87FINV91501017784252

MM PRAXIS L.L.C. 2025