The clinical research competency platform
Competency Labs helps clinical research professionals demonstrate role-relevant capability, close specific development gaps, and carry credible evidence forward through the Competency Passport. It grew out of years of hands-on training, coaching and placement work in this industry.
Who Competency Labs is
Competency Labs is a clinical research simulations and competency assessment platform. BORAKA is the parent brand; YANA Careers, LLC remains the operating legal entity.
Competency Labs was founded by Rudy Mallé, who has 15+ years across pharma, CRO and site clinical operations and is an internationally qualified clinical research trainer. The company operates as YANA Careers, LLC from Washington, DC, and that remains the legal entity behind everything published here.
The platform references the BORAKA Verified Competence Standard for Clinical Research (BORAKA-VCS-CR-001), a citable specification for how competence evidence is described, assessed, verified and shared.
Role profiles, simulations and review criteria are written in house by people who have done the work, with practice, review and evidence kept distinct.
Practice is developmental. Human-reviewed evidence is limited to the role, scope, date and version assessed. Nothing here guarantees employment, salary or promotion.
The problem, the premise and the standard
Competence is re-proven at every door
A coordinator with eight years on oncology protocols still starts each contract by emailing certificates. Sites wait. Trials slip. Nothing about the delay makes the work safer.
Assess the capability, then build on it
Standing belongs to the professional, not to a vendor database. We assess where your capability actually stands, help you close the specific gaps, and turn demonstrated work into evidence others can read.
Written for the reviewer, not the brochure
Every record is built to be read later: dated, attributable and current. If something lapses, the record says so.
Capability you can evidence.
Our mission is to help professionals build capability that is real, demonstrate it in a way others can read, and carry that evidence wherever they work next.
The platform runs on one loop: assess where you stand, simulate the real work, develop the specific gaps, reassess, and put human-reviewed evidence to work through the Competency Passport. A professional who already demonstrates the required capability can proceed toward verification without being required to buy training.
- 1Assess
- 2Simulate
- 3Develop
- 4Reassess
- 5Verify
- 6Passport
The vision is a capability layer for life-sciences work: portable, current and readable by the people making decisions. Clinical research is where the need is sharpest. The same gap runs through pharmacovigilance, medical affairs, regulatory and manufacturing quality, where the work demands proven competence and hiring cannot confirm it.
For employers, the same system supports better workforce decisions: reviewing demonstrated work rather than claims alone, and developing the team already in place.
Meet the founder
Rudy Mallé brings his clinical research experience to the practice and review design. Individual trainer accreditation is not product accreditation.
Rudy Mallé
Founder and lead capability strategist
- Accreditation
- IAOCR Accredited Clinical Research Trainer, Q-IAOCR Trainer accreditation, Trainer #16167194
- Experience
- 15+ years across site, sponsor and CRO clinical operations
- Outcomes
- Professionals supported through clinical research training, career coaching, and managed job-search services.
Rudy Mallé was born and raised in Cameroon, and that global perspective still shapes the work. His clinical research career started at a small research site in Queens, New York, learning the craft one protocol, one patient visit and one regulatory binder at a time.
From there he moved to institutions including Weill Cornell Medicine, Northwell Health and NewYork-Presbyterian, working across oncology, diabetes, respiratory, cardiology and rare disease. Those years built a deep appreciation for how trials actually run at the patient level.
He then crossed to the sponsor and CRO side in clinical operations and project management roles at Dendreon, ICON and IQVIA. Over 15+ years he has seen clinical research from nearly every angle: entry-level monitoring to senior leadership, site to sponsor, single study to global program.
Along the way he earned Q-IAOCR accreditation from the International Accrediting Organization for Clinical Research, as an IAOCR accredited clinical research trainer delivering career-focused education. Competency Labs exists because the structured, expert-guided path into this industry did not exist when he was starting out.
How we hold the line
The rules that decide what enters a capability record, and what never does.
Pathway before purchase
Start with free practice. Readiness guidance is optional and based on supplied answers, not demonstrated performance.
Demonstrated, not declared
Capability is assessed and reviewed against defined criteria by people who have done the job. Practice feedback is developmental; only human-reviewed work becomes verified evidence.
The holder owns the record
Professionals see every view of their Competency Passport and carry it between employers intact. Sharing is always permission-controlled.
Say the limits out loud
Where a method is weaker or a claim would overreach, we write it on the page rather than leave it implied.
Assessment, development and evidence in one system
Each part produces something the next part uses, which is what makes the record worth carrying.
Competency Labs
Free developmental practice and deeper account-based clinical research simulations.
Try Free PracticeHuman review
Separate assessment, trained reviewer workflows and defined evidence boundaries. Role availability and eligibility apply.
Explore human reviewCompetency Passport
A permission-controlled record of assessed scope, status, dates and limitations.
See the PassportHow we assess
Read the rubrics, versioning and human-review process without exposing active assessment answers.
Read the methodWhat verification means here, and what it does not
Verification means a person met defined requirements and demonstrated specified capability through Competency Labs casebooks, simulations, assessments or reviewed evidence. It is always reviewed by a person against criteria written down in advance.
- Assists practice: coaching prompts, role-play and drafting help.
- Organizes material and drafts summaries a person then edits.
- Flags for attention, never for exclusion.
- Review submitted work against published criteria and record the outcome.
- Decide whether something is strong enough to enter a capability record.
- Write the feedback a learner receives on assessed work.
- No black-box ranking, and no hidden score sorting a shortlist.
- No predictive claim. Reviewed work shows what someone did, not future performance.
- Assessment supplements interviews, references and credential checks.
- Practice feedback is developmental. Only reviewed work becomes evidence.
- Assistants protect personal data and make no hiring decisions.
- Nothing an assistant says replaces a protocol, SOP, medical or legal advice.
BORAKA is not a background-check, employment-verification, school-validation, certificate-authentication, licensing or accreditation service, and makes no guarantee of employment.
Read the full methodAbout the IAOCR Accredited Trainer designation
IAOCR accredits individual trainers, not training providers or their courses. Here is exactly what our use of the phrase means, and what it does not.
- Competency Labs founder, Rudy Mallé, is an IAOCR Accredited Clinical Research Trainer and holds Q-IAOCR Trainer accreditation, Trainer #16167194.
- IAOCR accredits Rudy Mallé as an individual trainer. BORAKA, its programs, courses, assessments, and certificates are not represented as IAOCR accredited, approved, or certified.
- The accreditation recognizes his knowledge, teaching competence and professional standards as a clinical research trainer.
- Competency Labs is not itself an IAOCR accredited organization.
- No BORAKA program, curriculum, course or cohort is IAOCR accredited, approved or certified.
- A BORAKA certificate of completion is issued by BORAKA only. It is not an IAOCR certificate, credential or license.
- Completing a BORAKA program does not confer any IAOCR accreditation on the learner.
Begin with your role
See where your capability stands today, then build, verify and carry the evidence forward.
