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Clinical Advisory Services Agreement

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Clinical Advisory Services Agreement

This Clinical Advisory Services Agreement (the "Agreement") is entered into as of by and between Advisor Name: , Advisor Address: , and Client Name: , Client Address: .

Recitals

WHEREAS, Client is engaged in the development, clinical evaluation, regulatory preparation and commercialization of pharmaceutical, biologic or medical device products and requires external clinical expertise to advise on clinical strategy, trial design, safety monitoring and related matters;

WHEREAS, Advisor has specialized experience, credentials and expertise in clinical development, clinical operations and medical affairs and is willing to provide advisory services to Client on the terms and conditions set forth in this Agreement;

WHEREAS, the parties desire to set forth their respective rights and obligations with respect to the provision of such advisory services.

NOW THEREFORE

NOW THEREFORE, in consideration of the mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. Scope of Services

1.1 Services. Advisor shall provide clinical advisory services to Client as described in the scope of work below, which may include protocol review, clinical development strategy, safety and risk management advice, investigator selection and trial conduct recommendations, and participation in advisory meetings (the "Services").

2. Term; Termination

2.1 Term. The term of this Agreement shall commence on the Effective Date and continue for unless earlier terminated in accordance with this Section.

2.2 Termination for Convenience. Either party may terminate this Agreement for convenience upon written notice to the other party delivered at least days prior to the effective date of termination.

2.3 Termination for Cause. Either party may terminate for material breach if the breaching party fails to cure the breach within thirty (30) days after receipt of written notice specifying the breach. Termination shall be without prejudice to any remedies available at law or in equity.

3. Compensation and Expense Reimbursement

3.1 Fees. As compensation for the Services, Client shall pay Advisor the fees set forth below and in any Work Order executed under this Agreement.

3.2 Invoicing and Payment. Advisor shall invoice Client monthly (or as otherwise agreed). Client shall pay all undisputed invoices within days of receipt. Overdue amounts shall accrue interest at the lesser of 1.5% per month or the maximum permitted by law.

4. Confidentiality

4.1 Definition. "Confidential Information" means any non-public, proprietary or confidential information disclosed by one party to the other relating to business, technology, clinical data, patient information, regulatory submissions, manufacturing, or other matters reasonably understood to be confidential.

4.2 Obligations. Each receiving party shall (a) use Confidential Information solely to perform its obligations under this Agreement; (b) restrict disclosure to its employees, contractors and advisors with a need to know and who are bound by confidentiality obligations at least as protective as those herein; and (c) exercise at least reasonable care to protect Confidential Information.

4.3 Exceptions. Confidential Information does not include information that (i) is or becomes publicly known through no breach hereof; (ii) is rightfully received from a third party without confidentiality obligation; (iii) is independently developed without use of Confidential Information; or (iv) is required to be disclosed by law, provided the disclosing party is given prompt notice and opportunity to seek protective relief.

5. Intellectual Property

5.1 Background IP. Each party retains all rights, title and interest in any intellectual property owned or controlled by it prior to the Effective Date or developed independently of this Agreement ("Background IP").

5.2 Work Product. Subject to Advisor’s ownership of its Background IP and moral rights, all original clinical advice, reports, slide decks and deliverables specifically prepared for Client in the performance of Services (the "Work Product") shall be owned by Client and Advisor hereby assigns such Work Product to Client. Advisor grants Client a perpetual, worldwide, royalty-free license to use any Background IP incorporated into Work Product to the extent necessary for Client’s use of the Work Product.

6. Conflicts; Compliance

6.1 Conflicts. Advisor represents that, to Advisor’s knowledge, no actual conflict of interest exists that would materially impair Advisor’s ability to perform the Services. Advisor shall promptly disclose any potential or actual conflict to Client in writing.

6.2 Regulatory Compliance. Advisor shall comply with all applicable laws, regulations and industry codes in performing Services, including those relating to the protection of human subjects and confidentiality of patient information. Advisor shall not make any representations to regulators on behalf of Client absent express written authorization.

7. Representations; Warranties; Indemnification

7.1 Mutual Representations. Each party represents and warrants that it has the full corporate or individual power and authority to enter into this Agreement and to perform its obligations hereunder.

7.2 Advisor Warranty. Advisor warrants that the Services will be performed in a professional and workmanlike manner consistent with generally accepted industry standards. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, ADVISOR DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

7.3 Indemnification. Each party (the "Indemnifying Party") shall indemnify, defend and hold harmless the other party and its officers, directors, employees and agents (the "Indemnified Party") from and against any third-party claims, liabilities, losses, damages and expenses (including reasonable attorneys' fees) arising out of (a) the Indemnifying Party’s breach of this Agreement, (b) the gross negligence or willful misconduct of the Indemnifying Party, or (c) Advisor’s negligent performance of clinical advisory activities.

8. Insurance

Advisor shall maintain professional liability insurance and, if applicable, general liability and workers’ compensation insurance in commercially reasonable amounts and shall provide certificate(s) of insurance upon Client’s request.

9. Independent Contractor

The parties acknowledge and agree that Advisor is an independent contractor and not an employee, agent or partner of Client. Advisor shall be responsible for all taxes and benefits applicable to Advisor and Advisor’s personnel.

10. Non-Solicitation

During the term of this Agreement and for twelve (12) months thereafter, neither party shall knowingly solicit for employment any employee or consultant of the other party who was involved in the performance of this Agreement without the other party’s prior written consent.

11. Notices

All notices required or permitted under this Agreement shall be in writing and delivered to the addresses set forth below (or such other address as a party may designate by written notice) by certified mail, overnight courier, or email with confirmation of receipt.

12. Amendments; Waiver; Counterparts

12.1 Amendments. This Agreement may not be amended except by a written instrument signed by authorized representatives of both parties.

12.2 Waiver. No failure or delay by a party in exercising any right shall operate as a waiver of that right, and any waiver must be in writing signed by the waiving party.

12.3 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument. Signatures delivered by electronic means shall be binding.

13. Governing Law; Dispute Resolution

13.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the state specified below without regard to conflict of laws principles.

13.2 Dispute Resolution. The parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement through negotiation. If the dispute cannot be resolved within sixty (60) days, the parties agree to submit the dispute to binding arbitration administered by a neutral forum in the jurisdiction specified above, unless otherwise agreed in writing.

14. Entire Agreement; Severability

14.1 Entire Agreement. This Agreement, together with any executed Work Orders, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior discussions, negotiations and understandings.

14.2 Severability. If any provision of this Agreement is held to be invalid or unenforceable, the remaining provisions shall remain in full force and effect and the parties shall negotiate in good faith to replace the invalid or unenforceable provision with a valid provision that most closely approximates the intent and economic effect of the invalid provision.

Additional Terms

Advisor Name:

By:

Date:

Client Name:

By:

Date:

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What a Clinical Advisory Services Agreement Covers

A Clinical Advisory Services Agreement is a written contract that sets the relationship between a sponsor or company and one or more clinical advisors or an advisory board. It defines services (consultation, protocol review, educational activities), term, compensation, deliverables, confidentiality obligations, intellectual property allocation, and termination rights. The agreement allocates responsibilities for regulatory compliance, conflicts of interest disclosure, and recordkeeping. For healthcare contexts, it often references HIPAA protections and data-handling procedures when advisors access patient-level or protected health information.

Why this agreement matters for clinical programs

A clear Clinical Advisory Services Agreement reduces ambiguity about duties, fees, and compliance obligations, and creates an auditable trail of advisor interactions that supports regulatory readiness and corporate governance.

Why this agreement matters for clinical programs

Who typically prepares and signs these agreements

Role clarity in the agreement reduces delays, supports disclosure reporting, and helps manage conflicts of interest.

  • Pharmaceutical and biotech sponsors coordinating advisory boards, protocol design, or investigator engagement.
  • Healthcare systems and medical device firms seeking clinician input on product development or clinical strategy.
  • Academic investigators and contract research organizations (CROs) who engage external advisors for methodological review.

Typical signers and their responsibilities

Company Signatory

Chief Medical Officer or authorized contracting officer signs for the sponsor and accepts financial, confidentiality, and deliverable obligations on behalf of the company. They confirm budget, reporting channels, and any required regulatory disclosures.

Advisor Signatory

Clinician or scientific advisor signs to accept scope, compensation, IP terms, and confidentiality. The advisor also attests to any conflicts of interest and provides professional credentials required by the sponsor.

Essential compliance and security considerations

HIPAA: BAA required if PHI is exchanged
ESIGN / UETA: Electronic signatures enforceable
Data Encryption: TLS 1.2/1.3 in transit
Data at Rest: AES-256 encryption
Audit Trail: Timestamped signing logs
21 CFR Part 11: Applicable for FDA-regulated records

Key risks of an incomplete or incorrect agreement

Regulatory Exposure: HIPAA violations
Contract Disputes: Unclear deliverables
Financial Liability: Incorrect payment terms
IP Ambiguity: Unresolved ownership
Conflict Reporting: Undisclosed COIs
Evidence Gaps: Poor audit trail

Common pitfalls to avoid

  • Vague scope language that leaves key activities undefined, which causes billing and performance disputes later.
  • Using non-standard or inconsistent advisor credentials and titles, producing mismatched records for compliance reviews.
  • Failing to attach required privacy addenda or a Business Associate Agreement when advisors access protected health information.
  • Not specifying termination triggers or payment proration, which increases post-termination reconciliation work.

Step-by-step: completing a Clinical Advisory Services Agreement

Follow this sequence to prepare, review, and finalize the agreement efficiently and with compliance in mind.

  • 01
    Draft scope: Describe specific advisory tasks and deliverables.
  • 02
    Set compensation: Specify fees, expenses, and invoicing schedule.
  • 03
    Add compliance terms: Include HIPAA, confidentiality, and COI clauses.
  • 04
    Execute: Obtain signatures and retain the executed copy.

Typical lifecycle from request to execution

A common operational flow speeds stakeholder reviews and ensures an auditable record for compliance or inspection.

  • Request: Business requests advisor engagement and scope.
  • Internal review: Legal and compliance review terms and budget.
  • Advisor sign-off: Advisor reviews, negotiates, and signs.
  • Recordkeeping: Store executed agreement and related invoices.

Six clauses to include in every Clinical Advisory Services Agreement

Explicit clauses reduce ambiguity and support regulatory and corporate governance obligations; include the following key provisions tailored to the relationship.

Scope of Services

Define tasks, time commitments, deliverables, meeting cadence, and any required written or oral reports. Be precise about activities that are outside scope.

Compensation

State fee amounts, expense reimbursement rules, invoicing cadence, payment terms, and whether payments are contingent on deliverables or milestones.

Confidentiality

Require nondisclosure of proprietary information, define permitted disclosures, and include duration of confidentiality obligations.

Data Handling

If PHI is involved, attach a Business Associate Agreement and specify permitted uses, security controls, and breach notification procedures.

Intellectual Property

Allocate ownership of any work product, background IP, and specify any licence grants or assignment requirements.

Termination & Indemnity

Define termination for convenience or cause, notice periods, transition assistance, and indemnification obligations.

Configuring a digital signature workflow for this agreement

A consistent digital workflow reduces turnaround time and preserves an auditable trail for compliance and audits.

Field Configuration
Signature Field Use signer-specific signature field with date required.
Initials Place initials on each page where changes are expected.
Attachments Require CV/license upload where credentialing is necessary.
Authentication Use email + optional SMS or KBA for high-assurance signers.

Technical considerations for e-signing and e-submission

Confirm the platform can export a tamper-evident PDF with a certificate of completion and can satisfy retention and BAA requirements when needed.

  • Authentication: Email link or stronger MFA options.
  • Audit Trail: IP, timestamp, and action log.
  • Document Formats: PDF and DOCX support required.

Timing and critical deadlines to track

Track execution and related reporting deadlines to avoid payment or compliance issues; use a simple timeline tied to the effective date.

Effective Date Selection:

Specify in MM/DD/YYYY format; governs start of obligations.

Invoice Submission:

State invoice window (e.g., within 30 days of service) to ensure timely payment.

Expense Reimbursement:

Set substantiation period (e.g., 60 days) for receipts and approvals.

Term Renewal:

Define automatic renewal notice period, commonly 30–60 days.

Record Retention:

Retain executed agreement per company policy and applicable law.

Key milestones from engagement to closure

Use milestones to monitor performance, invoicing, and contract compliance across the engagement lifecycle.

01

Engagement Request

Sponsor issues a written request and preliminary scope.

02

Agreement Drafting

Legal and compliance prepare and negotiate terms.

03

Execution

Parties sign and the executed agreement is archived.

04

Closeout

Final invoices settled and records retained per retention policy.

Comparison: eSignature pricing and features for executing agreements

Vendor pricing models and compliance features vary; signNow appears first to align with the platform data used in this guide.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial Varies by vendor Varies by vendor Varies by vendor Varies by vendor
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No

Real-world scenarios where these agreements are used

Practical examples show how clauses and workflows apply in common projects.

Pharma Advisory Board

A sponsor engages clinicians for protocol input and advisory meetings

  • Advisors sign confidentiality and COI clauses
  • The executed agreement includes compensation schedules, travel reimbursement rules, and a BAA where de-identified patient data are shared for analysis.

Device Safety Review

A manufacturer contracts an external surgeon for device usability review

  • The advisor provides written feedback and participates in two remote sessions
  • The agreement specifies deliverables, IP treatment for suggested improvements, and retained meeting minutes for regulatory filing.

Practical tips for faster, more reliable completion

Follow administrative and legal best practices to reduce cycle time and compliance risk when engaging advisors.

Standardize templates
Use a templated agreement with optional clauses to minimize negotiation and ensure consistent compliance language across engagements.
Centralize approvals
Route agreements through a single legal/compliance reviewer to avoid inconsistent redlines and missed privacy requirements.
Collect credentials up front
Request CVs, licenses, and COI disclosures during intake to speed verification and contracting.
Use e-sign with audit logs
Choose a solution that provides timestamped audit trails, tamper-evident PDFs, and, when needed, a BAA for HIPAA compliance.

Frequently asked questions about Clinical Advisory Services Agreements

Answers to common questions on signing, notarization, confidentiality, and recordkeeping for advisory engagements.


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